Physio-Control, Inc.: Device Recall

Recall #Z-2499-2025 · 07/22/2025

Class II: Risk

Recall Details

Recall Number
Z-2499-2025
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
1 unit

Reason for Recall

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

Product Description

LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). The cprCOACHTM Feedback Technology in the LIFEPAK CR2 defibrillator is indicated for use on cardiopulmonary arrest patients and provides CPR guidance in accordance with the AHA Guidelines for patients 1 year of age or older. The LIFEPAK CR2 defibrillator is intended for use by personnel who have been trained in its operation. Users should have received training in basic life support/AED, advanced life support, or a physician-authorized emergency medical response training program.

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.