FDA recall Z-2498-2025

Physio-Control, Inc. · Class II · device

Product

LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.

Reason for recall

Due to required inspections not being performed on products/units that have gone through servicing.

Distribution

U.S. Nationwide distribution in the states of CO and MT.

Key facts

Status
Ongoing
Initiation date
2025-07-22
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2498-2025