Recall Z-0811-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
Biphasic LIFEPAK 12 defibrillator / monitor.
| Date | Feb 22, 2010 (initiated Mar 31, 2009) |
| Status | Terminated |
| Reason | Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a notification letter dated March 2009 that explained firm representatives would follow up with each customer within 30 days to arrange an update to affected devices. Affected Biphasic PCBAs will be replaced. Customers advised to keep the devices in use and to continue to perform daily User Test. |
| Quantity | 1718 |
| Distribution | Distributed domestically and internationally to hospitals, clinics, etc. Foreign distribution to the following countries: Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063510 | LIFEPAK 12 DEFIBRILLATOR/MONITOR Medtronic Emergency Response Systems, Inc., Jan 26, 2007 |