Z-0887-2007
Batteries used with the LIFEPAK 20 defibrillator/monitor
Physio Control, Inc. / initiated 2007-03-30 / Terminated
Medtronic Emergency Response Systems, Inc. began a recall of Batteries used with the LIFEPAK 20 defibrillator/monitor on . The reason FDA records is "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". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0887-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Physio Control, Inc.
- Product
- Batteries used with the LIFEPAK 20 defibrillator/monitor
- Product code
- MJK Dna Probe, Trichomonas Vaginalis
- 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.
- FDA root cause
- Other
- Action
- 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.
- Quantity in commerce
- 3002
- Distribution
- Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
- Product codes and lots
- Battery Product Part Number: 3200497-000 Battery lot codes: prior to 0539; lot codes: 05 265 or 05 266
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