Recall Z-0116-06 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Medtronic Emergency Response Systems, Inc.
QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series.
| Date | Nov 2, 2005 (initiated Sep 2, 2005) |
| Status | Terminated |
| Reason | Potential for voltage pins in connector of therapy cable to break. |
| Root cause | Other |
| Action | On 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing, |
| Quantity | total for both types - 52,654 |
| Distribution | Devices were distributed worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012274 | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER Medtronic Physio-Control Corp., Feb 5, 2002 |