Recall Z-1548-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
The LIFEPAK12 Defibrillator/Monitor. The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a defibrillation shock is needed by looking at the ECG rhythm display. Advisory mode can be useful durin
| Date | Mar 4, 2011 (initiated Oct 1, 2010) |
| Status | Terminated |
| Reason | L1FEPAK 12 Operating Instructions that describe the process for disconnecting the device from AC (wall) power are not always being followed. When the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing. |
| Root cause | Device Design |
| Action | Physio Control, Inc. began mailing the URGENT-MEDICAL DEVICE INFORMATION letter to their consignees on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were advised to follow the current LIFEPAK 12 Operating Instructions-Section 7.5-AC Power Adapter Operation and wait at least 2 seconds to push the Power ON button after disconnecting the device from AC power. If the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power and the service indicato |
| Quantity | 39, 180 units (17168 units internationally and 22012 units in US) |
| Distribution | Worldwide Distribution - USA and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOR |
| 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 |