Physio-Control, Inc.: Device Recall

Recall #Z-2498-2025 · 07/22/2025

Class II: Risk

Recall Details

Recall Number
Z-2498-2025
Classification
Class II
Product Type
Device
Recalling Firm
Physio-Control, Inc.
Status
Ongoing
Date Initiated
07/22/2025
Location
Redmond, WA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Reason for Recall

Due to required inspections not being performed on products/units that have gone through servicing.

Product Description

LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

Distribution Pattern

U.S. Nationwide distribution in the states of CO and MT.

Other Recalls by Physio-Control, Inc.

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.