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Terminated

LIFEPAK 12 defibrillator/monitor.

FDA Recall Z-0938-04 · Posted 2004-07-20

Recalling FirmMedtronic Physio Control Corp
Recall StatusTerminated
Product CodeLDD
Date Initiated2004-04-05
Date Terminated2005-01-06
Product Quantity2885

Reason for Recall

Potential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.

Firm Action

Letters dated April 2004 were sent to customers on 4/6/04. The letter explains that a service representative will visit the customer and check the capacitor.

Root Cause

Other

Distribution Pattern

Devices were distributed to hospitals and medical centers throughout the US. The firm also distributed units internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012274MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKERMedtronic Physio-Control Corp. · 2002-02-05

Official Source

View FDA Recall →

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

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