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Terminated

Physio-Control LIFEPAK 12 defibrillator/monitor. The LIFEPAK12 defibrillator/monitor series is a battery operated portable external defibrillator with monitor used by healthcare providers in EMS, hospital and clinic settings. The LIFEPAK 12 has both manual and semi-automatic defibrillation operations. When clinically indicated, the LIFEPAK 12 defibrillator/monitor allows the operator to deliver a brief, high-energy shock to the heart of the patient. Operators may pre-configure the device to reduce complexity during normal operation.

FDA Recall Z-1858-2008 · Posted 2008-09-11

Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2008-05-08
Date Terminated2013-09-04
Product Quantity1,710 Units

Reason for Recall

The LIFEPAK12 defibrillator/monitor series (LP12) 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.

Firm Action

Starting May 8, 2008, letters were hand-delivered by the firm's service representatives as they visited customer sites to perform on-site service for affected units. Customers who had not been visited by May 16th were mailed a Certified Receipt letter on May 16, 2008. The letter explained the recall and notified customers that Physio Control was conducting a Field correction to replace all affected Biphasic PCBA. The firm recommends customers continue to perform therapy cable or Standard Paddles Defibrillation Check (monthly or as needed); to have a backup device available until their device is updated; and if no backup device is available, a loaner would be provided by the firm upon request. Contact Technical Support at 1-800-442-1142, option 5 - 6:00 am to 4:00 pm (Pacific), Monday -Friday or visit www.Physio-Control-notices.com/LP12.

Root Cause

Process control

Distribution Pattern

Product distributed nationwide to 5 Department of Defense accounts, 1 VA account, 5 government accounts, 49 hospitals, 223 first responders, and 1 direct account. 8 foreign accounts include: NETHERLANDS, MEXICO, JAPAN, HONG KONG, GERMANY, CANADA and AUSTRALIA.

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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