LIFEPAK CR Plus defibrillator. The device is a battery operated, portable automated external defibrillator (AED). The devices are designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, or public libraries.
FDA Recall Z-0671-2007 · Posted 2007-03-29
Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2007-03-02
Date Terminated2012-04-26
Product Quantity13,835 units
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.
Firm Action
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
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.