LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The de
FDA device recall Z-0671-2007 · posted 2007-03-29 · Terminated
Recall details
- Recalling firm
- Medtronic Emergency Response Systems, Inc.
- Reason for recall
- LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.
- Action taken
- Firm sent letters on 03/02/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK CR Plus devices. The firm advised consignees to upgrade their devices' software, and indicated that each consignee will be provided a user-installable software upgrade for their device(s) within 45 days.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MKJ
- Quantity affected
- 13,835 units
- Distribution
- Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries.
- Date initiated
- 2007-03-02
- Date posted
- 2007-03-29
- Date terminated
- 2012-04-26
- 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 |