Physio-Control, Inc.: Device Recall

Recall #Z-2497-2025 · 07/22/2025

Class II: Risk

Recall Details

Recall Number
Z-2497-2025
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
4 units

Reason for Recall

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

Product Description

LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

Distribution Pattern

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

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.