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Terminated

Biphasic LIFEPAK 12 defibrillator / monitor.

FDA Recall Z-0811-2010 · Posted 2010-02-22

Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2009-03-31
Date Terminated2013-08-08
Product Quantity1718

Reason for Recall

Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient.

Firm Action

Consignees were sent a notification letter dated March 2009 that explained firm representatives would follow up with each customer within 30 days to arrange an update to affected devices. Affected Biphasic PCBAs will be replaced. Customers advised to keep the devices in use and to continue to perform daily User Test.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed domestically and internationally to hospitals, clinics, etc. Foreign distribution to the following countries: Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063510LIFEPAK 12 DEFIBRILLATOR/MONITORMedtronic Emergency Response Systems, Inc. · 2007-01-26

Official Source

View FDA Recall →

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

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