Recall Z-1050-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052
| Date | Mar 29, 2008 (initiated Jan 8, 2008) |
| Status | Terminated |
| Reason | Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA). |
| Root cause | Nonconforming Material/Component |
| Action | The firm contacted Customers by phone and by Urgent-Medical Device Recall letters sent via return receipt requested to their consignees on 1/8/08. The letter advised consignees that the Printed Circuit Board Assemblies (PCBA) might not meet quality requirements. This manufacturing deviation could lead to eventual PCBA corrosion that could render the device inoperative and not ready for use in an emergency under battery power. The firm recommended keeping the unit in service until it could be replaced. Representatives will visit each consignee and replace units. |
| Quantity | 103 total devices - 84 domestic, 19 international |
| Distribution | Worldwide Distribution --- USA including states of OK, SC, TX, and WA, and country of Germany. |
| 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 |