LIFEPAK 20 defibrillator/monitor. The device is an AC powered defibrillator device with battery backup. The defibrillato
FDA device recall Z-0886-2007 · posted 2007-07-04 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.
- Action taken
- Firm sent letters on 03/30/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK 20 devices. The firm advised consignees to use the Operator's Checklist in the Operating Instructions to perform daily user tests and function checks while operating the defibrillator on battery power. In addition consignees are advised to replace their battery every 1 to 2 years.
- Root cause
- Other
- Status
- Terminated
- Product code
- MJK
- Quantity affected
- 26418
- Distribution
- Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
- Date initiated
- 2007-03-30
- Date posted
- 2007-07-04
- Date terminated
- 2011-05-04
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274) | Medtronic Physio-Control Corp. | 2002-02-05 |