The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx,
FDA device recall Z-1082-2013 · posted 2013-04-10 · Terminated
Recall details
- Recalling firm
- Physio Control, Inc.
- Reason for recall
- LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
- Action taken
- The firm start sending the "URGENT MEDICAL DEVICE CORRECTION LIFEPAK CR Plus AND LIFEPAK EXPRESS AEDs" letter, dated February 2013, to their consignees. Consignees are advised to check the readiness of the AEDs and should contact Physio if the OK symbol is NOT visible and either the ATTENTION or WRENCH symbols are present. In the event a device is returned to Physio-Control for assessment, the firm will analyze it to determine if it is affected by the early internal battery depletion issue. If it is verified the device is affected, the consignee will be provided with a permanent replacement device. Customers with questions can visit the firm's website www.physio-control-notices.com/CHARGE-PAK or call Technical Support at 1-800-442-1142.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 54,197 units in US and 78,627 units internationally (total 132, 824 units)
- Distribution
- Worldwide Distribution.
- Date initiated
- 2013-02-08
- Date posted
- 2013-04-10
- Date terminated
- 2015-11-05
- Location
- Redmond, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR (K011144) | Medtronic Physio-Control Corp. | 2001-12-03 |