LIFEPAK CR Plus defibrillator

FDA device recall Z-0836-2007 · posted 2007-06-21 · Terminated

Recall details

Recalling firm

Medtronic Emergency Response Systems, Inc.

Reason for recall

Premature battery depletion due to electrical component failure

Action taken

Per request from Japan, the firm initiated action on 10/5/06 replacing the devices in Japan with new devices. On 3/2/07 the firm issued a Safety Alert letter dated February 2007 to consignees (with the exception of Japan), advising that the defibrillators have an identified, lead-free component that is susceptible to failure within the first 250 days after manufacture. Failure of this component might cause a short that will drain the battery and eventually render the device inoperative. The letter further states that the firm strongly recommends that the consignee immediately and on a regular basis, inspect their defibrillator(s) per the LIFEPAK CR Plus/EXPRESS Operating Instructions - Section 5 Caring for the Defibrillator. The letter also provides a website to allow consignees to enter their device serial number(s) to determine if their LIFEPAK CR Plus/LIFEPAK EXPRESS are included in the action. This recall strategy is subject to modification pending the performance of devices remaining on the market.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MKJ

Quantity affected

Total of CR Plus 13,741 units worldwide; amount does not include units distributed to Japan.

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, and public libraries.

Date initiated

2006-10-05

Date posted

2007-06-21

Date terminated

2013-08-08

Location

Redmond, WA

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