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Terminated

LIFEPAK 20 defbrillator/monitor

FDA Recall Z-0984-05 · Posted 2005-07-13

Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeLDD
Date Initiated2005-06-17
Date Terminated2006-05-06
Product Quantity3924 units

Reason for Recall

The defibrillator may not operate if the device is turned on during an AC Loss Alert.

Firm Action

On 6/17/05 the firm issued a medical device correction letter to customers advising of the problem, explained what to do if the situation occurs, and that a service representative will visit and install new software.

Root Cause

Other

Distribution Pattern

Devices were distributed to hospitals and medical centers worldwide.

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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