Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.
FDA device recall Z-2388-2008 · posted 2008-09-21 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.
- Action taken
- On 06/18/08 the firm, via regular postal service , mailed an "IMPORTANT MEDICAL DEVICE NOTIFICATION" letter to all their consignees. The letter instructs consignees that the coin battery may deplete prematurely and to contact Physio-Control if their Lifepack 20 defibrillator/monitor requires coin battery replacement prior to the recommended four year replacement schedule. If you have any questions, contact Technical Support at 1-800-442-1142, option 5 from 6:00 am to 4:00 pm (Pacific), Monday-Friday or visit www.physio-control-notices.com/coin battery.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 45,209 devices
- Distribution
- There were 24,238 devices distributed to 3,135 consignees throughout the United States and 20,613 devices distributed to 48 foreign consignees.
- Date initiated
- 2008-06-18
- Date posted
- 2008-09-21
- Date terminated
- 2013-09-04
- 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 |