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Terminated

LIFEPAK 500 automated external defibrillator (AED)

FDA Recall Z-0546-06 · Posted 2006-02-22

Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2006-02-01
Date Terminated2008-03-06
Product Quantity2100 domestically, 1980 internationally

Reason for Recall

Component leads may have intermittent connection to the printed circuit board assembly pads - which could render the device inoperative.

Firm Action

On 2/1/06 the firm issued an UREGENT MEDICAL DEVICE CORRECTION letter to customers via certified return receipt. The letter advised customers of the issue and recommended customers inspect their AED at least weekly. The letter also advised customers what to do when readiness indicator displays certain symbols. The firm''s representatives will visit customers to replace the main circuit board assembly.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Devices were distributed domestically to first responder type consignees and internationally to distributors.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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