Class II

Medical Device Recall: 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

Physio-Control, Inc. · August 30, 2024

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

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

States Affected

CT, GA, MA, NY, OH, WA, WV

Quantity Affected

105 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0230-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.