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Terminated

Physio-Control Lifepak 20 defibrillator/monitor is intended for the termination of certain fatal arrhythmias.

FDA Recall Z-2388-2008 · Posted 2008-09-21

Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-06-18
Date Terminated2013-09-04
Product Quantity45,209 devices

Reason for Recall

Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.

Firm Action

On 06/18/08 the firm, via regular postal service , mailed an "IMPORTANT MEDICAL DEVICE NOTIFICATION" letter to all their consignees. The letter instructs consignees that the coin battery may deplete prematurely and to contact Physio-Control if their Lifepack 20 defibrillator/monitor requires coin battery replacement prior to the recommended four year replacement schedule. If you have any questions, contact Technical Support at 1-800-442-1142, option 5 from 6:00 am to 4:00 pm (Pacific), Monday-Friday or visit www.physio-control-notices.com/coin battery.

Root Cause

Nonconforming Material/Component

Distribution Pattern

There were 24,238 devices distributed to 3,135 consignees throughout the United States and 20,613 devices distributed to 48 foreign consignees.

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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