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
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Reason for Recall
Firm Action
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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