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
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