Physio-Control, Inc.: Device Recall

Recall #Z-1232-2025 · 02/03/2025

Class II: Risk

Recall Details

Recall Number: Z-1232-2025
Classification: Class II
Product Type: Device
Recalling Firm: Physio-Control, Inc.
Status: Ongoing
Date Initiated: 02/03/2025
Location: Redmond, WA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1

Reason for Recall

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.

Product Description

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

Distribution Pattern

U.S.: WV O.U.S.: N/A

Other Recalls by Physio-Control, Inc.

Class II: Risk 07/22/2025

Due to required inspections not being performed on products/units that have gone through servicing.
Class II: Risk 07/22/2025

Due to required inspections not being performed on products/units that have gone through servicing.
Class II: Risk 07/22/2025

Due to required inspections not being performed on products/units that have gone through servicing.
Class II: Risk 01/21/2025

Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
Class II: Risk 01/21/2025

Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions

View all recalls by Physio-Control, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.