Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052
FDA Recall Z-1050-2008 · Posted 2008-03-29
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Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-01-08
Date Terminated2013-09-04
Product Quantity103 total devices - 84 domestic, 19 international
Reason for Recall
Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).
Firm Action
The firm contacted Customers by phone and by Urgent-Medical Device Recall letters sent via return receipt requested to their consignees on 1/8/08. The letter advised consignees that the Printed Circuit Board Assemblies (PCBA) might not meet quality requirements. This manufacturing deviation could lead to eventual PCBA corrosion that could render the device inoperative and not ready for use in an emergency under battery power. The firm recommended keeping the unit in service until it could be replaced. Representatives will visit each consignee and replace units.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution --- USA including states of OK, SC, TX, and WA, and country of Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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