FDA recall Z-0230-2025

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.

Reason for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-08-30

Report date

2024-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0230-2025