FDA-Device2024-11-06Class II
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.
Physio-Control, Inc.
Hazard
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Sold states
U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A
Affected count
105 systems
Manufactured in
11811 Willows Rd Ne, N/A, Redmond, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0230-2025Don't want to check this manually?
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