FDA recall Z-1232-2025
Physio-Control, Inc. · Class II · device
Product
LIFEPAK 20e REF 99507-000001 The AED mode is to be used only on patients in cardiopulmonary arrest.
Reason for recall
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Distribution
U.S.: WV O.U.S.: N/A
Key facts
- Status
- Ongoing
- Initiation date
- 2025-02-03
- Report date
- 2025-03-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Redmond, WA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1232-2025