Recall Z-2388-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.
| Date | Sep 21, 2008 (initiated Jun 18, 2008) |
| Status | Terminated |
| Reason | Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate. |
| Root cause | Nonconforming Material/Component |
| Action | On 06/18/08 the firm, via regular postal service , mailed an "IMPORTANT MEDICAL DEVICE NOTIFICATION" letter to all their consignees. The letter instructs consignees that the coin battery may deplete prematurely and to contact Physio-Control if their Lifepack 20 defibrillator/monitor requires coin battery replacement prior to the recommended four year replacement schedule. If you have any questions, contact Technical Support at 1-800-442-1142, option 5 from 6:00 am to 4:00 pm (Pacific), Monday-Friday or visit www.physio-control-notices.com/coin battery. |
| Quantity | 45,209 devices |
| Distribution | There were 24,238 devices distributed to 3,135 consignees throughout the United States and 20,613 devices distributed to 48 foreign consignees. |
| 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 |