Physio-Control, Inc.: Device Recall

Recall #Z-0230-2025 · 08/30/2024

Class II: Risk

Recall Details

Recall Number: Z-0230-2025
Classification: Class II
Product Type: Device
Recalling Firm: Physio-Control, Inc.
Status: Ongoing
Date Initiated: 08/30/2024
Location: Redmond, WA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 105 systems

Reason for Recall

Due to an out of tolerance tool being used on monitor/defibrillator systems.

Product Description

LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.

Distribution Pattern

U.S.: CT, GA, MA, NY, OH, WA, and 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 02/03/2025

Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
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.

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.