Recall Z-0887-2007 ยท MJK Dna Probe, Trichomonas Vaginalis
Medtronic Emergency Response Systems, Inc.
Batteries used with the LIFEPAK 20 defibrillator/monitor
| Date | Jul 4, 2007 (initiated Mar 30, 2007) |
| Status | Terminated |
| Reason | 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. |
| 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 | 3002 |
| Distribution | Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.