AED Update & Recall Center
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The AED Recall Center is a service of Rescue Training Institute. It is intended to give a snapshot of updates and recalls for most of the AEDs on the market today. It is not meant to be all inclusive of AED recalls for each manufacturer nor for every product that our featured manufacturers produce. Please go to the FDA's website for medical device recalls for up to the moment AED recall information.
Date: 01/13/12
Title: Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall,
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.
Date: 6/29/10
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
Date: 2/3/10
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
Date: 11/13/09
Title: Voluntary Medical Device Correction: AED resistor and AED relay
Fix: Install mandatory software update on all models
Date: 10/9/09
Title: Factory-Testing Corrective Action
Fix: If on the list, send unit to CS for testing
Date: 6-2-10
Title: Voluntary recall: Specific Philips HeartStart HS1 and FRx Defibrillators
Affected Devices: Affected devices are HS1 (models M5066A and M5068A) and FRx
(model 861304) automated external defibrillators. The HS1 defibrillators are sold in
North America as HeartStart OnSite and HeartStart Home, and internationally as
HeartStart HS1 and HeartStart Home 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.
Date: 02-12-09
Title: ZOLL Medical Corporation, 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.
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.
For more information about this recall, please see the company’s website at: http://www.ZOLLAEDPlusbatteryhelp.com
Date: 03-14-11
Title: Defibtech LLC, Lifeline and ReviveR AEDs: Software Defect May Cancel Shock
Product(s): 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.
Fix: Customers can check the nine-digit serial number on the back of their AED against the list published by Defibtech at http://www.defibtech.com/fa11 to see if their devices are affected.
Date: 5-21-10
Title: Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED®
Semi-automatic External Defibrillators
Product(s): DBP-2800 Battery Pack for the Defibtech ReviveR AED™ and Lifeline
AED® semi-automatic external defibrillators
Affects only DBP-2800 battery packs distributed prior to June 4, 2007 and used with
the ReviveR AED™ and Lifeline AED® devices.
Affected battery pack serial numbers range:
• Between 202001005 and 202005916, or,
• Between 206001001 and 206009871
Fix: Contact Defibtech for correction
Date: 7-31-09
Title: Physio-Control Inc., LIFEPAK CR Plus Automated External Defibrillators (AEDs)
Product: Only the 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
The serial number is located on the underside of the device.
Reason for Recall: 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
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