Recall Z-1057-2012
Cardiac Science Corporation · initiated January 13, 2012
Product
Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Responder 2019198, 2023440 AEDs. The Powerheart AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. The device is intended to be used by personnel who have been trained it is operation. The user should be qualified by training in basic life support or other physician-authorized medical response.
Codes / lots: Serial Numbers: 4372713, 4373884, 4373898, 4373902, 4373904, 4373906, 4373908, 4373913, 4373915, 4373917, 4373920, 4373922, 4373923, 4373925, 4373927, 4373931, 4373938, 4373944, 4373945, 4373946, 4373947, 4373949, 4373951, 4373952, 4373955, 4373956, 4373958, 4373959, 4373960, 4373965, 4373991, 4373993, 4373998, 4374002, 4374009, 4374010, 4374011, 4374012, 4374013, 4374014, 4374015, 4374018, 4374021, 4374023, 4374032, 4374035, 4374038, 4374050, 4374052, 4374053, 4374055, 4374056, 4374061, 4374065, 4374077, 4374082, 4374086, 4374096, 4374098, 4374102, 4374106, 4374110, 4374111, 4374115, 4374119, 4374137, 4374143, 4374151, 4374154, 4374159, 4374161, 4374165, 4374174, 4374175, 4374180, 4374181, 4374182, 4374183, 4374186, 4374188, 4374191, 4374193, 4374196, 4374203, 4374204, 4374209, 4374210, 4374212, 4374215, 4374220, 4374230, 4374235, 4374240, 4374244, 4374257, 4374275, 4374283, 4374285, 4374286, 4374288, 4374294, 4374297, 4374299, 4374368, 4374369, 4374370, 4374372, 4374375, 4374377, 4374378, 4374380, 4374389, 4374390, 4374394, 4374396, 4374399, 4374427, 4374428, 4374429, 4374431, 4374435, 4374440, 4374442, 4374446, 4374454, 4374459, 4374463, 4374465, 4374487, 4374488, 4374491…
Reason for recall
The affected Automated External Defibrillators (AEDs) contains 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.
FDA-determined cause: Process control
Action taken
Cardiac Science sent an "URGENT-Voluntary Medical Device Recall" letter dated January 13, 2012 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to immediately return the device to the manufacturing location for repair. The affected devices will receive a hardware correction, and the same serial number device returned to the consignee in most cases. Customers in the US can call 1-888-402-2484 and customers outside the US can call 1-425-402-2482 or email at aed210@cardiacscience.com to arrange delivery of the shipping materials. Customers can also visit www.cardiacscience.com/aed210 for more information about AEDs affected by this recall.
Details
- Recall number
- Z-1057-2012
- Initiated
- January 13, 2012
- Posted by FDA
- February 27, 2012
- Terminated
- September 27, 2013
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 11,019 units (6142 units in the US and 4877 units international)
- Distribution
- Worldwide distribution: USA (nationwide) and Puerto Rico; and to the following countries: Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Malaysia, Maldives, Malta, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar…
- Recalling firm
- Cardiac Science Corporation, Bothell, WA