Recall Z-1410-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, Washington USA. The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient protocols.
| Date | Apr 21, 2010 (initiated Mar 4, 2010) |
| Status | Terminated |
| Reason | Potential for the device to power off then on by itself, or to power off by itself and requiring the operator to turn it back on, or the device doesn't turn off. |
| Root cause | Device Design |
| Action | Physio-Control Inc. issued an "Urgent Medical Device Correction" notification dated March 2010 to domestic consignees. Foreign consignees were notified by overseas representatives. Consignees were advised to keep the affected device in service and to test the units in accordance with operating instructions. They were further advised that a local service representative will call and schedule a service visit within 60 days. Consignees were asked to forward the notification to all of their sites and to notify the recalling firm if they no longer own the device. For further information, cont |
| Quantity | 3,609 |
| Distribution | Worldwide Distribution -- United States, Netherlands, Germany, Canada, Australia, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082937 | LIFEPAK 15 MONITOR/DEFIBRILLATOR Physio-Control, Inc., Mar 11, 2009 |