Recall Z-0710-06 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Emergency Response Systems, Inc.
LIFEPAK 12 defibrillator/monitor
| Date | Apr 4, 2006 (initiated Mar 22, 2006) |
| Status | Terminated |
| Reason | Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions. |
| Root cause | Nonconforming Material/Component |
| Action | On 3/22/06, the firm began sending out letters dated March 2006, and flagged URGENT MEDICAL DEVICE CORRECTION. The letters advised customers of the issue and that a service representative would visit and inspect the therapy connector sockets, and replace the therapy connector and the mating cable if short drill sockets are found. |
| Quantity | 942 devices |
| Distribution | Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010918 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM Medtronic Physio-Control Corp., Aug 23, 2001 |