Physio Control, Inc.: 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.

Recall number

Z-1858-2008

Recalling firm

Physio Control, Inc.

Product

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.

Status

Terminated

Initiated

2008-05-08

Posted

2008-09-11

Terminated

2013-09-04

Reason

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.

Root cause

Process control

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.

Quantity

1,710 Units

Distribution

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.

Lot, serial or model codes

Part Nbr 3010178-010, DVLP12-02-000102, UVLP12-02-000022, VLP12-02-000021, VLP12-02-000022, VLP12-02-000023, VLP12-02-000057, VLP12-02-000058, VLP12-02-000059, VLP12-02-000099, VLP12-02-000100, VLP12-02-000107, VLP12-02-000110, VLP12-02-000242, VLP12-02-000287, VLP12-02-000296, VLP12-02-000317, VLP12-02-000338, VLP12-02-000411, VLP12-02-000449, VLP12-02-000577, VLP12-02-000800, VLP12-02-000801, VLP12-02-000876, VLP12-02-000983, VLP12-02-000985, VLP12-02-001029, VLP12-02-001038, VLP12-02-001168, VLP12-02-001253, VLP12-02-001366, VLP12-02-001387, VLP12-02-001430, VLP12-02-001449, VLP12-02-001460, VLP12-02-002163, VLP12-02-002175, VLP12-02-002222, VLP12-02-002250, VLP12-02-002860, VLP12-02-003223, VLP12-02-003585, VLP12-02-003809, VLP12-02-003979, VLP12-02-004055, VLP12-02-004221, VLP12-02-004354, VLP12-02-006000, VLP12-02-006011, VLP12-02-006012, VLP12-02-006013, VLP12-02-006018, VLP12-02-006020, VLP12-02-006021, VLP12-02-006030, VLP12-02-006033, VLP12-02-006036, VLP12-02-006037, VLP12-02-006042, VLP12-02-006044, VLP12-02-006057, VLP12-02-006060, VLP12-02-006064, VLP12-02-006067, VLP12-02-006076, VLP12-02-006077, VLP12-02-006081, VLP12-02-006086, VLP12-02-006087, VLP12-02-006088, VLP12-02-006097, VLP12-02-006101, VLP12-02-006103, VLP12-02-006107, VLP12-02-006110, VLP12-02-006114, VLP12-02-006119, VLP12-02-006159, VLP12-02-006176, VLP12-02-006179, VLP12-02-006181, VLP12-02-006196, VLP12-02-006199, VLP12-02-006202, VLP12-02-006210, VLP12-02-006223, VLP12-02-006226, VLP12-02-006234, VLP12-02-006238, VLP12-02-006256, VLP12-02-006263, VLP12-02-006266, VLP12-02-006267, VLP12-02-006268, VLP12-02-006269, VLP12-02-006275, VLP12-02-006290, VLP12-02-006304, VLP12-02-006306, VLP12-02-006312, VLP12-02-006315, VLP12-02-006322, VLP12-02-006329, VLP12-02-006333, VLP12-02-006343, VLP12-02-006349, VLP12-02-006359, VLP12-02-006365, VLP12-02-006366, VLP12-02-006367, VLP12-02-006373, VLP12-02-006393, VLP12-02-006396, VLP12-02-006398, VLP12-02-006414, VLP12-02-006423, VLP12-02-006437, VLP12-02-006455, VLP12-02-006457, VLP12-02-006475, VLP12-02-006478, VLP12-02-006483, VLP12-02-006487, VLP12-02-006500, VLP12-02-006531, VLP12-02-006542, VLP12-02-006555, VLP12-02-006565, VLP12-02-006576, VLP12-02-006577, VLP12-02-006578, VLP12-02-006593, VLP12-02-006600, VLP12-02-006615, VLP12-02-006623, VLP12-02-006624, VLP12-02-006644, VLP12-02-006647, VLP12-02-006686, VLP12-02-006687, VLP12-02-006723, VLP12-02-006747, VLP12-02-006748, VLP12-02-006757, VLP12-02-006780, VLP12-02-006789, VLP12-02-006823, VLP12-02-006836, VLP12-02-006845, VLP12-02-006863, VLP12-02-006911, VLP12-02-006922, VLP12-02-006941, VLP12-02-006945, VLP12-02-006965, VLP12-02-007013, VLP12-02-007028, VLP12-02-007029, VLP12-02-007066, VLP12-02-007098, VLP12-02-007133, VLP12-02-007143, VLP12-02-007170, VLP12-02-007174, VLP12-02-007189, VLP12-02-007209, VLP12-02-007211, VLP12-02-007212, VLP12-02-007213, VLP12-02-007214, VLP12-02-007215, VLP12-02-007217, VLP12-02-007218, VLP12-02-007220, 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510(k) numbers

["K991910"]

PMA numbers

not on file

Product code

MKJ

Firm FEI

3015876

Firm city

Redmond

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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