LIFEPAK 12 defibrillator/monitor.
FDA device recall Z-0938-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Physio Control Corp
- Reason for recall
- Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.
- Action taken
- Letters dated April 2004 were sent to customers on 4/6/04. The letter explains that a service representative will visit the customer and check the capacitor.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDD
- Quantity affected
- 2885
- Distribution
- Devices were distributed to hospitals and medical centers throughout the US. The firm also distributed units internationally.
- Date initiated
- 2004-04-05
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-06
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER (K012274) | Medtronic Physio-Control Corp. | 2002-02-05 |