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Terminated

LIFEPAK EXPRESS defibrillator

FDA Recall Z-0548-06 · Posted 2006-02-23

Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2006-01-31
Date Terminated2011-01-17
Product Quantity20,525 devices total - CR Plus and LIFEPAK Express

Reason for Recall

One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.

Firm Action

On 1/31/06 the firm sent a letter flagged URGENT-MEDICAL DEVICE RECALL to their customers via certified return receipt. The letter advised customers of the problem and requested the customers inspect their units at least weekly. The customers are provided additional guidance if they see certain symbols as described in the letter. The firm''s service personnel will visit the customers, remove and replace units.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Units were distributed worldwide to public access environments.

Official Source

View FDA Recall →

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

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