Batteries used with the LIFEPAK 20 defibrillator/monitor
This recall has been terminated (originally issued July 4, 2007).
- Recall Initiated
- March 30, 2007
- Posted
- July 4, 2007
- Terminated
- May 4, 2011
- Recall Number
- Z-0887-2007
- Quantity
- 3002
- Firm Location
- Redmond, WA
- Official Source
- View on FDA website ↗
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.
Distribution
Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
Lot / Code Info
Battery Product Part Number: 3200497-000 Battery lot codes: prior to 0539; lot codes: 05 265 or 05 266
Root Cause
Other
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.