Recall Z-1232-2025— Physio-Control, Inc.

Name: FDA recall Z-1232-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-03

Class II · Ongoing

Class II FDA medical device recall by Physio-Control, Inc., initiated 2025-02-03. FDA's recall record names no specific 510(k) clearance for this event. Product: LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.. Reason: Incorrect keypad was incorrectly installed onto a defibrillator/monitor..

Recalling firm: Physio-Control, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-02-03
Firm location: Redmond, WA, United States

Product description

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

Reason for recall

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Data sourced from openFDA. This site is unofficial and independent of the FDA.