CURRENT RECALL / SOFTWARE UPGRADE / END OF LIFE NOTICE

Philips FR2/FR2+ End of Life - Stoppage of Accessories

On December 31, 2012, Philips announced its intention to discontinue the HeartStart FR2/FR2+. Six years later on December 31, 2018, Philips announced end of life support for HeartStart FR2/FR2+ AEDs and most FR2/FR2+ accessories. This letter is to inform you that Philips will not ship any of the products/accessories to US locations after February 2, 2021. In order to accommodate this stoppage of shipments, the last day to place orders for the HeartStart FR2/FR2+ AED accessories listed below will be December 31, 2020.
Philips Announcement

Posted 7/16/2020

Physio-Control, Stryker - Infant Child Electrodes Class 2 Recall

Physio-Control, Stryker is conducting a voluntary correction for specific Infant Child Reduced Energy Electrodes that were manufactured by the electrode manufacturer, Cardinal Health, Inc. Affected electrodes were enclosed in packaging that may have compromised packaging seals. This recall affects Infant Child Reduced Energy Electrodes manufactured between August 2017 through October 2019. These electrodes are designed for use with the LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator. If you prefer speaking to someone call Stryker tech support at 1-800-787-9537 option 2.
Stryker SAFETY NOTICE and CORRECTION

Acknowledgement and Receipt Form - Response is Required

Created 6/11/2020 FDA Link

Physio-Control LifePak 500 End of Life Announcement, Class 2 Recall

LIFEPAK 500 AEDs in high-use environments (Emergency Medical Services) may detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. Wear-through of the connector exposes base metal on which an oxide layer may form result in the device not recognizing a patient is connected. When the circumstance arises, the device will provide the user the "CONNECT ELECTRODES" message. In agreement with the FDA and the PMA standards, this device is out of service.
Posted 4/1/2020 FDA Link

Philips HeartStart HS1 Onsite and HSI Home AED Class 2 Recall

Philips HeartStart HS1 Onsite and HSI Home AED Class 2 Recall. Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards. The Recalling Firm or distributors will contact customers to arrange for replacement and removal of affected devices.
Created 2/19/2020 FDA Link

Philips HeartStart FRx AED Class 2 Recall

Philips HeartStart FRx AED Class 2 Recall. Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards
Created 2/19/2020 FDA Link

FDA Approved AEDs

The FDA has published a list of the currently approved AEDs that meet the newest standards for "Premarket Approval" (PMA). Please make sure to review this list and check that all your devices are compliant. Contact our knowledgable staff to learn
if any of your AEDs may need a software update or replacement. Understanding Premarket Approval (PMA).
Posted 2/3/2020 FDA Link

Physio-Control, Stryker LifePak CR-Plus and LifePak Express End of Life Announcement

Physio-Control LifePak CR-Plus and Express "End of Life" announcement.
Stryker Announcement
Posted 11/27/2019

HeartSine Samaritan 300/300P End of Life Announcement

HeartSine Samaritan 300/300P. In agreement with the FDA and the PMA standards, this device is out of service.
Stryker Announcement
Posted 9/30/2019

Zoll Medical AED Pro AED Class 2 Recall

ZOLL AED Pro Defibrillator, Class 2 Recall: There is a potential for the device to fail to deliver energy to the patient. AED to be replaced by Zoll Medical.
Serial Number List
Created 7/3/2019 FDA Link

Philips HeartStart FR3 AED Class 2 Recall

Philips HeartStart FR3 AED Class 2 Recall. Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Created 10/18/2018 FDA Link

Philips HeartStart Infant/Child SMART Pads Cartridge Class 2 Recall

Philips HeartStart Infant/Child SMART Pads Cartridge. The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.
Created 9/20/2018 FDA Link

Philips HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs Class 2 Recall

Onsite (A13A-xxxxx or A13B-xxxxx) and FRx Automated External Defibrillators (B04L-xxxxx through B13B-xxxxx). Philips HeartStart FRx, HeartStart OnSite, or HeartStart Home automated external defibrillators (AEDs) manufactured between 2002 and 2013. Philips is voluntarily issuing this recall notification due to awareness of isolated failures with one of the device's electrical components (a resistor).
Philips Announcement
Created 5/23/2018 FDA Link

Philips HeartStart FRx and Home AED Class 2 Recall

An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
Created 5/23/2018 FDA Link FRX, FDA Link Home

Physio-Control Infant Defibrillation Electrodes Class 1 Recall

Model/Item Numbers: 11101-000016 and 11101-000017Lot codes: 713609, 717912, 713904, 718033, 715008, 719323, 45932237, 46042286,45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054,46023823, 46078012 Manufacturing Dates: April 27, 2017 to August 10, 2017Distribution Dates: May 30, 2017 to September 4, 2017 Devices Recalled in theU.S.: 7,973 units nationwide. Physio-Control Inc. is recalling infant/child defibrillation electrodes because the artwork on the pads within the packaging shows incorrect placement instructions for infants. There is no issue with the performance or function of the defibrillation electrodes. However, incorrect placement of the electrodes on an infant may result in failure to deliver an effective shock to an infant in cardiac arrest. A delay in therapy could result in serious injury and/or death.
Posted 12/12/2017 FDA Link

Philips - FDA Consent Decree (FRx  FR3)

According to the complaint filed with the consent decree, Philips was responsible for the manufacture and distribution of adulterated devices because its AEDs and Q-CPR Meters were made in violation of current good manufacturing practice (CGMP) requirements under the FD&C Act based on noncompliance with quality system (QS) regulations. The complaint notes that the company failed to establish and maintain adequate processes regarding its corrective and preventative action procedures, design verification and validation controls, and product specifications.
Announcement
Posted 10/31/2017

Physio-Control LifePak 1000 AED Class 1 Recall

LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment. Customers are being advised to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. The removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. Physio-Control will be initiating a hardware device correction for all affected LIFEPAK 1000 devices and the company will contact customers to schedule device corrections once the hardware correction is ready for implementation. The company will provide customers with updated information regarding the timing for this device correction at the website URL shown below,when it is available.
Physio-Control Announcement
Physio-Control Action Required
Battery Removal Checklist
Posted 3/3/2017 FDA Link

Philips HeartStart MRx Defibrillators Class 1 Recall

Model/Item numbers: M3535A, M3536A.  Philips is recalling the HeartStart MRxDefibrillator due to a defect in the device's Gas Discharge Tube (GDT). The GDT has micro cracks which allows internal gasses to escape and causes the tubes to not function as expected. This also permits an electrical current surge to cross the device's designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED)mode. As a result of this GDT defect, the HeartStart MRx may fail at any time,including when delivering repeated shocks in AED mode, or during the periodicOperational Check outlined in the device's Instructions for Use. If the device is used in AED mode after failure, the device will not deliver patient therapy.Continued use of the device in AED mode after failure may lead to serious patient injury or death.
Posted 2/24/2017 FDA Link

Cardiac Science Electrode Class 2 Recall

9131-001 Defibrillator Electrodes, Lot No. 141125-02 Recalled for AED units Powerheart G3 9300A, 9300E, 9300p, 9390A, and 9390E AEDs. Contact our knowledgable staff to learn if any of your AEDs may need a software update or replacement.
Cardiac Science Announcement
Posted 3/9/2016 FDA Link

Philips HeartStart MRx Defibrillators Class 2 Recall

The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off.
Posted 11/20/2015 FDA Link

Cardiac Science End of Life Announcement

Effective January 1, 2016, Cardiac Science will no longer be able to repair, or provide batteries and electrodes for these devices:
-Burdick First Save Model 92531
-Burdick Cardiovive AT AED Model 92532
-Burdick Cardiovive DM Model 92533
-Cardiac Science Powerheart AED Model 9300A-2xx
-Cardiac Science Powerheart AED Model 9300E-2xx
-Cardiac Science Powerheart AED Model 9300P-2xx
-Cardiac Science Firstsave Model 9300C-xxx
-Cardiac Science Firstsave Powerheart Model 9300D-xxx
Cardiac Science Announcement
Posted 7/16/2015

ConMed PadPro and R2 Multi-Function Defibrillation Electrodes Class 2 Recall

Electrodes will not work with Philips FR3 and FRx AEDs. Philips made changes to the connector design of their FR3 and FRx AEDs. Because of these changes, the CONMED electrodes will no longer work with these AEDs. The FRx AED requires electrode pads be connected to the device before it is used. The AED will make a continuous alarm chirp to alert the user that the correct pads are not connected. The FR3 does not require electrode pads to be pre-connected. Users will not know that the pads do not work until they try to use the AED. This may result in a delay in delivering the electrical therapy needed to revive a patient. Delay in therapy could result in serious injury or death.
Posted 12/4/2014 FDA Link

Philips HeartStart Home, and Heartstart OnSite AEDs Class 2 Recall

Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
Philips Announcement
Posted 3/19/2014 FDA Link

Philips HeartStart FR3 AEDs Class 2 Recall

Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency.
Posted 3/19/2014 FDA Link

Philips HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs Recall

Onsite (A13A-xxxxx or A13B-xxxxx) and FRx Automated External Defibrillators (B04L-xxxxx through B13B-xxxxx). Philips HeartStart FRx, HeartStart OnSite, or HeartStart Home automated external defibrillators (AEDs) manufactured between 2002 and 2013. Philips is voluntarily issuing this recall notification due to awareness of isolated failures with one of the device's electrical components (a resistor).
Philips Announcement
Posted 11/19/2013

Physio-Control, Lifepak 500 AED Class 2 Recall

LIFEPAK 500 PART NUMBERS: 3011790-001568,3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650. The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.
Posted 7/19/2013 FDA Link

Physio-Control CR-Plus and Express AED Class 2 Recall

Physio-Control LIFEPAK CR Plus and LIFEPAKEXPRESS defibrillators. Product part's numbers: 3200731-xxx,3202177-xxx, U3200731-xxx,and U3202177-006. LIFEPAK CR Plus or LIFEPAK ExpressAutomated ExternalDefibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
Posted 4/10/2013 FDA Link

WelchAllyn AEDs End of Life Announcement

Welch Allyn announces the end of life for MRL Junpstart, MRL PIC, AED10, AED10 Trainer, AED20, PIC30, PIC40, and PIC50. Repair and services ended on December 31, 2012.
WelchAllyn Announcement
Posted 3/22/2013

Cardiac Science - Mandatory Software Update

This is to inform you a mandatory software updated fro all affected models is now available. The update enhances the AED's capability to detect the resistor issue during normal self-test procedures..
Cardiac Science Announcement

Posted 2/5/2013

Philips HeartStart FRx AED Class 2 Recall

Philips determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of their FRx (models 861304 and 861305), OnSite (models M5066A and M5067A), or HeartStart Home (model M5068A) automated external defibrillators (AEDs) shipped between December 2005 and July 2012.
Posted 1/4/2013 FDA Link

Philips HeartStart FR2+ End of Life Announcement

Philips HeartStart FR2+ defibrillator End of Life announcement.
Philips Announcement
Posted 12/28/2012

HeartSine Samaritan 300/300P Pad Battery Management Software Issue, Class 1 Recall

HeartSine Samaritan 300/300P PADs, Off/On issue, battery management software issue.
Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106
Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occurs, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emitted.
HeartSine Announcement
Posted 10/27/2012 FDA Link

Cardiac Science Circuit Board Recall

Cardiac Science is conducting a voluntary recall of a limited number of automated external defibrillators (AEDs) manufactured between July 1, 2011 and December 30, 2011. The affected AEDs contain a circuitboard manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy. This issue was detected at the Cardiac Science factory through our standard quality control processes. We have no reports of this issue impacting a rescue. This action is being conducted with the knowledge of the appropriate Regulatory Agencies. Cardiac Science Powerheart, CardioVive,CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated ExternalDefibrillators (AEDs) selected Powerheart models, 9300E, 9300P, 9390A, 9390E, 11,000 units worldwide.
Cardiac Science Announcement
Posted 1/13/2012

Physio-Control LifePak End of Life Announcement

Physio-Control LifePak Discontinued Products Letter. Factory configured useful life is 8 years after date of manufacture.
Physio-Control Announcement
Posted 11/1/2011

Physio-Control LifePak 500 AED Class 2 Recall

Physio-Control LifePak 500 AED Recall. The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly.
Posted 7/26/2011 FDA Link

Defibtech Lifeline and ReviveR AEDs: Software Defect May Cancel Shock Class 1 Recall

Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. 65,885 AEDs distributed in the United States are subject to this recall. AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.
Defibtech Announcement
Defibtech Serial Number Link
Posted 5/16/2011 FDA Link

Philips HeartStart HS1 FRx and FR2+, FDA Warning Letter

The FDA letter noted multiple Philips defibrillator problems, such as an issue with detached or missing magnets that has generated 87 complaints since early 2008, including one patient death. The FDA said Philips's responses missed the mark because "they do not address the quality system observation indicating that no evaluation of the effectiveness of the corrective action was performed or documented."
FDA Announcement
Posted 4/1/2011

Philips HeartStart FR2 Defibrillators with Text Display Class 2 Recall

Model 3861 automated external defibrillators. A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.
Posted 11/29/2010 FDA Link

Philips HeartStart FRx AED Class 3 Recall

The affected device may not deliver appropriate defibrillation therapy.
Posted 11/22/2010 FDA Link

Cardiac Science Mandatory Software Update

Posted 6/29/2010

Philips HeartStart FRx, HeartStart Home, and Heartstart OnSite AEDs Class 2 Recall

AEDs failed production line testing (Final Acceptance Test).
Posted 6/28/2010 FDA Link FRx, FDA Link Home, FDA Link Onsite

Defibtech DBP-2800 Battery Pack for ReviveR AED Class 1 Recall

Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED Recall
Posted 6/10/2010 FDA Link

Philips Specific Philips HeartStartHS1 and FRx Defibrillators Recall

HS1 (models M5066A and M5068A) and FRx (model861304) automated external defibrillators. The units affected by the recall were manufactured by Philips in March 2010.
Posted 6/2/2010

Cardiac Science Powerheart G3 AED, Class 1 Recall

Cardiac Science, Automated External Defibrillator (AED) under the following brand names (with respective model numbers): Powerheart AED G3: 9300A, 9300C, 9300D, 9300E, 9300P, 9390A/E; CardioVive: 92532 and 92533; Nihon Kohden: 9200G, and 9231; and Responder: 2019198 and 2023440. Powerheart G3 AEDs may not have received adequate electrical safety testing prior to being shipped from the factory. Affected models are: Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198 and 2023440. The affected devices were manufactured between October 29, 2003 and February 10, 2009.
Posted 4/27/2010 FDA Link

Cardiac Science Powerheart G3 AED, Model 9300A, 9300E, 9300P, 9390A, 9390E Class 2 Recall

A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy.
Posted 4/6/2010 FDA Link 9300A, FDA Link 9300E, FDA Link 9300P, FDA Link 9390A, FDA Link 9390E

Philips HeartStart OnSite AED Class 2 Recall

Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
Posted 3/23/2010 FDA Link

Philips HeartStart FRx AED Class 2 Recall

Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
Posted 3/23/2010 FDA Link

Cardiac Science Powerheart G3 AED, Model 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E Class 1 Recall

Potential for devices not to deliver therapy.
Posted 3/4/2010 FDA Link 9300A, FDA Link 9300C, FDA Link 9300D, FDA Link 9300E, FDA Link 9300P, FDA Link 9390A, FDA Link 9390E

Cardiac Science Corp. Powerheart and CardioVive AED Recall

The problems include interrupted electrocardiography analysis, failure to recognize pad placement during use, and interference from background noise that makes the device unable to analyze the heart rhythm and deliver a shock regardless of electrocardiogram analysis.
Cardiac Science Announcement
Posted 11/13/2009  

Physio-Control LifePak CR-Plus AED Class 1 Recall

Physio-Control LifePak CR-Plus AEDs. The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.
Posted 9/14/2009 FDA Link

WelchAllyn AED 10 automatic external defibrillator and MRL Jumpstart Class 2 Recall

Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing soon. If a user experiences a flashing low battery status indicator and does not understand that the device can continue to be used, the user might choose not to continue operating the device, thereby causing therapy to be discontinued.
Posted 7/6/2009 FDA Link

WelchAllyn AED 10 automatic external defibrillator and MRL Jumpstart Class 2 Recall

Welch Allyn AED10 or MRL JumpStart defibrillator Part numbers 970300x, 970302x, 970308x, 970309x, 970310x, 970311x, where "x" specifies the language as English, Dutch, Danish, Chinese, French, German, Italian, Polish, Spanish, or European English. Low Energy Shock, Electromagnetic Noise Interference, Unexpected Shutdown During Use, Blown Fuse, Loss of Voice Prompts Shutdown in Cold Temperatures.
Posted 6/23/2009 FDA Link

Zoll Medical Battery Software Update, Class 1 Recall

ZOLL AED Plus Defibrillator, Class 1 Recall Units Recalled: This product was manufactured from May, 2004 through February, 2009 and distributed from May, 2004 through February 9, 2009. The AED failed to deliver the defibrillation energy. The company sent their distributors and customers an initial recall letter on February 12, 2009 by certified mail. This letter instructed customers to replace their batteries every three years. The company then sent their distributors and customers a follow-up recall letter on March 31, 2009 by certified mail. This letter instructed customers to download new software for their devices and to remove any battery replacement reminder labels.
Posted 4/1/2009 FDA Link

WelchAllyn AED 10 automatic external defibrillator and MRL Jumpstart Class 1 Recall

Potential for device to deliver less than the programmed energy.
Posted 3/10/2009 FDA Link

Cardiac Science Powerheart G3 AED, Model 9300A, 9300C, 9300E, 9390A, and 9390E Class 2 Recall

Potential for AED to not deliver defibrillation therapy..
Posted 2/25/2009  FDA Link 9300A, FDA Link 9300C, FDA Link 9300E, FDA Link 9390A, FDA Link 9390E

GE Responder AED manufactured by Cardiac Science Corporation Class 2 Recall

Potential for AED to not deliver defibrillation therapy..
Posted 2/25/2009  FDA Link

Burdick, Cardio Vive AED, manufactured by Cardiac Science Corporation Class 2 Recall

Potential for AED to not deliver defibrillation therapy..
Posted 2/25/2009  FDA Link

Physio-Control LifePak CR-Plus and Express Class 2 Recall

Physio-Control LifePak CR-Plus and Express AED Recall. The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
Posted 10/30/2008 FDA Link

Physio-Control LifePak 1000 Class 2 Recall

Physio-Control LifePak 1000. Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed.
Posted 9/16/2008 FDA Link

Physio-Control LifePak CR-Plus AED Class 1 Recall

Physio-Control LifePak CR-Plus AEDs. This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device.
Posted 9/16/2008 FDA Link

Physio-Control LifePak CR-Plus Software Recall

Physio-Control LifePak CR-Plus Software Recall. This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device.
Posted 2/2/2008

WelchAllyn AED 10 Class 1 Recall

WelchAllyn AED 10, Failure to Deliver Shock; a defective capacitor may cause the delay or non-delivery of the defibrillating shock which may result in failure to resuscitate the patient.
Posted 11/6/2007 FDA Link

WelchAllyn AED 20 Class 1 Recall

Failure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
Posted 9/19/2007 FDA Link

Physio-Control LifePak 500 AED Class 2 Recall

Physio-Control LifePak 500 AED Recall. The biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos.3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXXX . (XXXX indicates various non-contiguous numbers).  ReducedShock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.
Posted 8/4/2007 FDA Link

Physio-Control LifePak CR-Plus and Express AED Class 2 Recall

Physio-Control LifePak CR-Plus and Express Recall. Premature battery depletion due to electrical component failure.
Posted 6/21/2007 FDA Link

Physio-Control LifePak CR-Plus AED Class 2 Recall

Physio-Control LifePak CR-Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.
Posted 3/29/2007 FDA Link

Physio-Control LifePak CR-Plus AED Class 2 Recall

Physio-Control LifePak CR-Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement..
Posted 3/29/2007 FDA Link

Philips HeartStart FR2+ AED Class 2 Recall

Failure of tactile switches on one of two printed circuit board assemblies (PCBA) used in the FR2+ device. Potential delay or prevention of shock treatment due to PCBA board contamination, causing intermittent switch operation.
Posted 3/22/2007 FDA Link

Defibtech Lifeline and ReviveR AEDs Class 1 Recall

Defibtech Announces a Worldwide Voluntary Recall of Lifeline and ReviveR Automated External Defibrillators. The self-test software for these devices may allow a self-test to clear a previously detected low battery condition. If this situation occurs, the operator may be unaware of the low battery, and the device may be unable to deliver a defibrillation shock, which could result in failure to resuscitate a patient.
Defibtech Announcement
How to determine Your Defibtech AED's Software Version
Posted 3/8/2007 FDA Link

WelchAllyn AED 20 Class 1 Recall

The Welch Allyn AED 20 Defibrillators may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
Posted 6/22/2006 FDA Link

Cardiac Science Powerheart G3 AED, Model 9300A Class 2 Recall

Some Powerheart AED Model 9300A may contain a suspect electronic component and there is a remote likelihood that the function of this device may be interrupted during the charge.
Posted 3/2/2006  FDA Link

Physio-Control LifePak CR-Plus AED Class 2 Recall

Physio-Control LifePak CR-Plus, One of the printed circuit board assemblies maybe contaminated with solder flux which can cause a short that may render the device inoperative.
Posted 2/23/2006 FDA Link

Physio-Control LifePak Express AED Class 2 Recall

Physio-Control LifePak CR-Plus, Part number 3202177-00 through -002 Serial numbers. One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
Posted 2/23/2006 FDA Link

Physio-Control LifePak 500 Class 2 Recall

Physio-Control LifePak 500, Component leads may have intermittent connection to the printed circuit board assembly pads - which could render the device inoperative.
Posted 2/22/2006 FDA Link

Physio-Control LifePak 500 and CR-Plus AED Hard Case, Class 2 Recall

Physio-Control LifePak 500 and CR-Plus Hard Case Recall for some hard shell carry case for automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landing or mountain descent).  a) Hard shell carry case for the LifePak 500AED. Catalog number 3005384-000 through 002, Recall # Z-0004-06; b) Hard shell carry case for the LifePak CR Plus. Catalog number 3201582-000 through --002,Recall # Z-0005-06. Contact Physio-Control for replacement.
Posted 10/4/2005 FDA Link CR-Plus, FDA Link 500

Philips ForeRunner End of Life Announcement

As of March 31, 2006 the ForeRunner or Laerdal FR AED will no longer be supported.
Philips Announcement
Posted 9/22/2005

HeartSine Samaritan, Models: SAM 001, SAM 002, SAM 003 Class 2 Recall

HeartSine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within range of 0000101 and 00003986. Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition. Software upgrade is required.
Posted 7/28/2005 FDA Link

WelchAllyn AED 20 Class 1 Recall

The Welch Allyn AED 20 product may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
Posted 5/12/2005 FDA Link

HeartSine Samaritan, Models: SAM 001, SAM 002, SAM 003 Class 1 Recall

HeartSine Samaritan AED Defibrillators - Models: SAM 001, SAM 002, SAM 003. Serial numbers within the range of 1270 - 2324 (not all are affected). The affected Automatic External Defibrillators (AED) announce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition.
Posted 3/23/2005 FDA Link

Physio-Control LifePak 500 AED Class 1 Recall

Physio-Control LifePak 500 AED Class 1 Recall for automated external defibrillators (AEDs), part numbers 3005400-XXX, D3005400-XXX andU3005400-XXX. This action affects 1,924 devices. All were manufactured in 1997. The affected AEDs may display a "Connect Electrodes" message and then will not defibrillate the patient, even when the electrodes are properly connected.
Posted 3/10/2005 FDA Link

Cardiac Science Powerheart G3 AED, Model 9300A, 9300E, 9300P Class 2 Recall

AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not function properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is present it will delay the first defibrillation shock in the 3 shock sequence.
Posted 1/15/2005  FDA Link 9300A, FDA Link 9300E, FDA Link 9300P

Physio-Control LifePak 500 Battery Class 2 Recall

Physio-Control LifePak 500 AED, Potential for batteries to malfunction due to battery cell rupture.
Posted 7/20/2004 FDA Link

WelchAllyn AED 10 automatic external defibrillator Class 2 Recall

WelchAllyn AED 10, part numbers 970300 and 970302; serial numbers 4613, 4888/4891, 4897, 6369/6386, 6396/6704, 6706, 6709/6743, 6745/6803, 6806, 6807, 6809, 6811, 6813/6832, 6836/6838, 6853/6855, 6912, 6914, 6917, 6921, 6922, 6924/6926. A faulty component has been identified which could result in an intermittent shock button (button #3) failure on the AED10 defibrillator.
Posted 7/20/2004 FDA Link

Physio-Control LifePak CR-Plus AED Class 2 Recall

Physio-Control CR-Plus AED, for all serial numbers below 31058753l. Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
Posted 6/12/2003 FDA Link

Zoll Medical AED Plus AED Class 2 Recall

ZOLL AED Plus Defibrillator, Class 2 Recall: Defibrillator may fail to function due to false detection of safety fault condition. Serial Numbers: X02F000812 through X02K007486.
Posted 2/6/2003 FDA Link

Recalled Safety Equipment

LifeLine can help you keep your safety equipment and training up to date and compliant with Federal, State and local requirements. Start by calling us or checking on the status of your equipment.

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