Medical device recalls Moderate risk

Physio-Control, Inc. recalls LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

Recall date
February 3, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1232-2025
FDA classification
Class II
Brand / firm
Physio-Control, Inc.
Sold / distributed
U.S.: WV O.U.S.: N/A

Why it was recalled

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.

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