AED Recall Information

Past records illustrate the significant number of recalls on AED devices. It is extremely important you stay updated on this information and check that your device is not affected. Look at the list below or click on the link to our website for more detailed information on these recalls.  This list may not be all inclusive; if you find or have an AED recall that is not mentioned, please send us that update via email!

 

Recall Date: 01/13/2012
Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall.
Units: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs)
selected Powerheart models, 9300E, 9300P, 9390A, 9390E, 11,000 units worldwide.
Issue: 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 circuit board 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.
Fix: enter serial number, if on the list contact Cardiac Science and have repaired at no cost.
Alert Documentation
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Recall Date: 06/29/2010
Title: Mandatory Software Update for Field Correction: AED resistor and AED relay
Does your unit need to have the 11/13/09 corrective action?
Fix: enter serial number, if on the list download and install the software update
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/03/2010
Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall
Fix: If on the list, remove from service immediately. CS will replace the AED
Need help with recalls for your device? Contact Think Safe!
Recall Date: 11/13/2009
Title: Voluntary Medical Device Correction: AED resistor and AED relay
Fix: Install mandatory software update on all models
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/09/2009
Title: Factory-Testing Corrective Action
Fix: If on the list, send unit to CS for testing
Need help with recalls for your device? Contact Think Safe!
Recall Date: 12/03/2014
Title: PadPro and R2 Multi-Function Defibrillation Electrodes because they will not work with Philips FR3 and FRx AEDs.
Units:

  • Adult Radiotransparent Electrode
    • Catalog Number: 2001H, 2001H-C, 2001H-PC, 2516H, 2516H-PC
  • Pediatric Radiotranslucent Electrode
    • Catalog Number: 2603H
  • Mini Pediatric Radiotranslucent Electrode
    • Catalog Number: 2602H
  • Pediatric R2 Multifunction Electrode
    • Catalog Number: 3115-1750
  • R2 Multifunction Electrode
    • Catalog Number: 3115-1751

Issue: 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.
Need help with recalls for your device? Contact First Voice!
Recall Date: 03/14/2011
Title: Defibtech LLC, Lifeline and ReviveR AEDs: Software Defect May Cancel Shock
Units: 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.
Issue: 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.
Fix: Customers can check the nine-digit serial number on the back of their AED against the list published by Defibtech to see if their devices are affected.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 05/21/2010
Title: Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED
Units: DBP-2800 Battery Pack for the Defibtech ReviveR AED
Fix: Contact Defibtech for correction
Need help with recalls for your device? Contact Think Safe!
Recall Date: 09/12/2012
Title: HeartSine Samaritan 300/300P PAD Voluntary Recall
Units: HeartSine Samaritan 300/300P PADs, if your unit was recalled you will have received a letter directly from HeartSine.
Units affected are:
0400000501 – 0700032917
08A00035000 – 10A0070753
10C00200000 – 10C00210106
Issue: Off/On issue, battery management software issue.
Fix: Contact Think Safe 319-377-5125, 8 AM through 5 PM CST, Monday through Friday
Alert Documentation
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Recall Date: 07/19/2013
Title: 2013 class 2 recall of Lifepak 500 AED (all parties contacted so no remaining devices left to be upgraded)
Units: LIFEPAK 500 PART NUMBERS: 3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650.
Issue: 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.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 04/10/2013
Title: 2013 CR Plus and Express AED recall: (over 130,000 AEDs affected)
Units: LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part’s numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006.
Issue: LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 07/ 26/2011
Title: 2011 Lifepak 500 recall:
Units: LIFEPAK 500
Issue: 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.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 07/31/2009
Title: Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (AEDs)
Units: Physio-Control LIFEPAK CR PLUS AEDs with the serial numbers below are affected by this recall.
Serial Numbers:
37026963, 37026983, 37026984, 37026997, 37027002,37027008,
37027039, 37027040, 37027049, 37027053,
37027063, 37027065,
37027066, 37027070, 37027071, 37027073, 37027075, 37027090,
37027099, 37027105
37027122, 37027197, 37027529, 37027569,
37031393,
37037850, 37037893, 37037986, 37038002, 37038211,
37038365, 37135986, 37154526, 37154638
Issue: 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.
Fix: Contact Physio-Control Customer Care
1-800-442-1142, 6 AM through 4 PM Pacific Time
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/30/2008
Title: CR Plus 2008 recall:
Units: LIFEPAK CR Plus
Issue: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/30/2008
Title: 2008 Lifepak Express recall:
Units: LIFEPAK Express
Issue: The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 08/04/2007
Title: Lifepak 500 – 2007 recall
Units: 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)
Issue: Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/21/2007
Title: Lifepak Express – 2007 recall
Units: LIFEPAK EXPRESS defibrillator
Issue: Premature battery depletion due to electrical component failure
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/21/2007
Title: CR Plus – 2007 recall
Units: LIFEPAK CR Plus
Issue: Premature battery depletion due to electrical component failure
Need help with recalls for your device? Contact Think Safe!
Recall Date: 03/29/2007
Title: CR Plus – 2007 (march) recall
Units: LIFEPAK CR Plus
Issue: 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.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/23/2006
Title: CR Plus – 2006 recall
Units: LIFEPAK CR Plus
Issue: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/22/2006
Title: Lifepak 500 – 2006 recall
Units: LIFEPAK 500
Issue: Component leads may have intermittent connection to the printed circuit board assembly pads – which could render the device inoperative.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/19/2005
Title: Lifepak 500 – 2005 recall (cases)
Units: a) Hard shell carry case for the Lifepak 500 AED.
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
Issue: Some hard shell carry case for Lifepak 500 and Lifepak CR Plus 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).
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/04/2005
Title: Lifepak CR Plus – 2005 recall (cases)
Units: Hard shell carry case for the LIFEPAK CR Plus.
Issue: Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus 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 landng or mountain descent).
Fix: On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 03/10/2005
Title: Lifepak 500 2005 recalls
Units: LIFEPAK 500
Serial numbers – various, noncontiguous Part numbers – 3005400-XXX, D3005400-XXX, U3005400-XXX
Issue: Potential to not detect patients at the low end of the patient impedance range.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/03/2005
Title: Certain Medtronic LIFEPAK 500 Automated External Defibrillators
Class 1 Recall
Units: LIFEPAK 500 automated external defibrillators (AEDs), part numbers 3005400-XXX, D3005400-XXX and U3005400-XXX. This action affects 1,924 devices. All were manufactured in 1997.
Issue: The affected AEDs may display a “Connect Electrodes” message and then will not defibrillate the patient, even when the electrodes are properly connected.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 07/20/2004
Title: Lifepak 500 – 2004 recalls
Units: LIFEPAK 500
Issue: Potential for batteries to malfunction due to battery cell rupture.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/12/2003
Title: Lifepak CR Plus – 2003 recall
Units: LIFEPAK CR Plus
All serial numbers below 31058753
Issue: Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
Need help with recalls for your device? Contact Think Safe!
Recall Date:
Title: Lifepak Express – 2006 recall
Units: LIFEPAK EXPRESS
Part number 3202177-00 through -002 Serial numbers listed above with the CR Plus
Issue: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
Need help with recalls for your device? Contact Think Safe!
Recall Date:
Title: 2008 CR Plus recall:
Units: LIFEPAK CR Plus
Issue: 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.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 2/14/2014
Title: Feild Safety Notice: Contact Pin Contamination
Units: A limited number of Philips HeartStart Home and OnSite (HS1) models M5066A
and M5068A are affected by this action. Philips has identified the serial numbers
of all affected devices.
Issue: In a limited number of HeartStart Home and OnSite (HS1) AEDs, 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.
Fix: If you are have an affected device, please contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available
Monday through Friday, 7:00AM to 5:00PM PST. You can also leave a message
24 hours a day, seven days a week; a customer support representative will
return your call promptly on the next business day.

Please keep your AED in service until you receive a replacement if there are no
alternative defibrillators readily available.

Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 12/28/2012
Title: Philips HeartStart FR2+ defibrillator discontinuance
Units: FR2+
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 10/30/2012
Title: AED Maintenance Information
Issue: Philips wanted to inform FRx and OnSite HeartStart AED owners of potentially misunderstood alerts from their AEDs.
Alert Documentation
Need help with recalls for your device? Contact Think Safe!
Recall Date: 06/02/2010
Title: Voluntary recall: Specific Philips HeartStart HS1 and FRx Defibrillators
Units: HS1 (models M5066A and M5068A) and FRx
(model 861304) automated external defibrillators. The units affected by the recall
were manufactured by Philips in March 2010.
Fix: Perform serial number look up on company website, company will direct further if
your unit is affected.
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/25/2009
Title: Welch Allyn AED 10 Recall Information
Units: 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
Issue: Low Energy Shock, Electromagnetic Noise Interference, Unexpected Shutdown During Use, Blown Fuse, Loss of Voice Prompts Shutdown in Cold Temperatures
Fix: Contact Think-Safe (888)473-1777
Need help with recalls for your device? Contact Think Safe!
Recall Date: 02/12/2009
Title: ZOLL Medical Corporation, ZOLL AED Plus Defibrillator, Class 1 Recall
Units: 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.
Issue: The AED failed to deliver the defibrillation energy.
Fix: 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.
Need help with recalls for your device? Contact Think Safe!

GO GREEN. GET AED RECALLS & UPDATES.

We’re happy to help you with getting up to date! Please complete the form below and we will contact you. You may also call us at 888-473-1777 or email us at info@think-safe.com.

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