Biphasic LIFEPAK 12 defibrillator / monitor.
FDA device recall Z-0811-2010 · posted 2010-02-22 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 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, N
- Date initiated
- 2009-03-31
- Date posted
- 2010-02-22
- Date terminated
- 2013-08-08
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 12 DEFIBRILLATOR/MONITOR (K063510) | Medtronic Emergency Response Systems, Inc. | 2007-01-26 |