Physio-Control, Inc. recalls LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076

Recalled November 6, 2024 · FDA recall Z-0230-2025 · Physio-Control

Hazard

Due to an out of tolerance tool being used on monitor/defibrillator systems. · FDA Class II

Units

105 systems

Sold at

U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A

Description

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

Product

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.

Manufacturer(s)

Physio-Control, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →