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Terminated

LIFEPAK 20 automatic external defibrillator

FDA Recall Z-0295-2007 · Posted 2006-12-19

Recalling FirmMedtronic Emergency Response Systems, Inc.
Recall StatusTerminated
Product CodeLDD
Date Initiated2006-03-16
Date Terminated2011-03-29
Product Quantity10,307 devices as of 9-19-06

Reason for Recall

LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.

Firm Action

Letter dated December 2006 alerts users to the lock-up problem, and suggesting a procedure to prevent lock-up. Firm promised another letter in January 2007 detailing the plan to provide software upgrade.

Root Cause

Other

Distribution Pattern

Devices were distributed to hospitals and clinics 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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