Recall Z-1107-04 ยท MKJ Automated External Defibrillators (Non-Wearable)
Medtronic Physio Control Corp
LIFEPAK 12 defibrillator/monitor Part Numbers: VLP12-02-000000 through VLP12-02-005003, AVLP12-02-000000 through AVLP12-02-005003, DVLP12-02-000000 through DVLP12-02-005003, EVLP12-02-000000 through EVLP12-02-005003, FVLP12-02-000000 through FVLP12-02-005003, LVLP12-02-000000 through LVLP12-02-005003, PVLP12-02-000000 through PVLP12-02-005003, UVLP12-02-000000 through UVLP12-02-005003
| Date | Jul 20, 2004 (initiated May 5, 2004) |
| Status | Terminated |
| Reason | Therapy cable doesn't meet firm's standards/may not maintain connections sufficient to support ECG monitoring, external pacing or defibrillation; ECG connector with higher than normal connection resistance resulting in intermittent ECG signal; therapy connector has potential for impact damage. |
| Root cause | Other |
| Action | The firm reviewed records and/or contacted customers by telephone to verify affected devices used in the out of hospital mobile environment. All affected customers were notified by a letter dated May 2004. The firm''s service representative will contact customers to inspect and correct the devices. |
| Quantity | 20,676 domestic, 19,899 international |
| Distribution | The firm distributes to distributors, hospitals, EMT-Ds and paramedics nationwide. The firm also distibutes the product internationally. |
| 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 |