Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, W
FDA device recall Z-1410-2010 · posted 2010-04-21 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- 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.
- Action taken
- 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, contact Physio-Control Inc. Technical Support at 1-800-442-1142, Option 5, 6:00 am to 4:00 pm (Pacific), Monday-Friday.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 3,609
- Distribution
- Worldwide Distribution -- United States, Netherlands, Germany, Canada, Australia, and Hong Kong.
- Date initiated
- 2010-03-04
- Date posted
- 2010-04-21
- Date terminated
- 2012-01-03
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 15 MONITOR/DEFIBRILLATOR (K082937) | Physio-Control, Inc. | 2009-03-11 |