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Terminated

LIFEPAK 20 defibrillator/monitor. Product Part numbers: 3202487-xxx, 3202488-xxx, U3202487-000, 3202488-015, and U3202488-000.

FDA Recall Z-1903-2010 · Posted 2010-07-01

Recalling FirmPhysio Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2010-05-27
Date Terminated2014-10-21
Product Quantity43,001 units

Reason for Recall

A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power." A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not operate.

Firm Action

Firm began mailing Urgent Medical Device Correction notifications to affected customers on May 26, 2010 regarding the power supply to the device. All affected power supplies will be updated; this will be accomplished in two phases. Devices at a higher risk will be updated first in phase 1. The remaining lower risk devices will be updated afterward in Phase 2. Customers are advised to keep the defibrillators in service, and to follow recommended daily Operator Checklist steps, while service updates are scheduled. Customers with questions should contact the firm at 800-442-1142 between 6 am and 4 pm Pacific Time, Monday - Friday

Root Cause

Material/Component Contamination

Distribution Pattern

Worldwide distribution. In US, distributed domestically including to gov't accounts; and internationally to the following countries: ANGUILLA, ARGENTINA, AUSTRALIA, BAHAMAS, BAHRAIN, BARBADOS, BOLIVIA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, GERMANY, GUAM, GUATEMALA, HONG KONG, INDIA, IRAN, ISRAEL, JAMAICA, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PUERTO RICO, SAUDI ARABIA, SOUTH AFRICA, SYRIA, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIRGIN ISLANDS, and YEMEN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012274MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKERMedtronic Physio-Control Corp. · 2002-02-05

Official Source

View FDA Recall →

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

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