LIFEPAK 12 defibrillator/monitor
FDA device recall Z-0710-06 · posted 2006-04-04 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.
- Action taken
- On 3/22/06, the firm began sending out letters dated March 2006, and flagged URGENT MEDICAL DEVICE CORRECTION. The letters advised customers of the issue and that a service representative would visit and inspect the therapy connector sockets, and replace the therapy connector and the mating cable if short drill sockets are found.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 942 devices
- Distribution
- Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes h
- Date initiated
- 2006-03-22
- Date posted
- 2006-04-04
- Date terminated
- 2011-09-06
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM (K010918) | Medtronic Physio-Control Corp. | 2001-08-23 |