FDA recall Z-0567-2024

Physio-Control, Inc. · Class II · device

Product

AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098

Reason for recall

AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

Distribution

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

Key facts

Status
Ongoing
Initiation date
2023-11-06
Report date
2023-12-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Redmond, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0567-2024