Z-0567-2024 Class II Ongoing
FDA device recall Z-0567-2024 was initiated by Physio-Control, Inc. on November 6, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 18,732.
Recall Details
- Product Type
- Devices
- Report Date
- December 27, 2023
- Initiation Date
- November 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,732
Product Description
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 Pattern
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.
Code Information
UDI-DI: 00883873940204, Adapters manufactured between 11/3/2021 - 4/24/2023