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Recall Observatory FDA recall evidence

Device product

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

Z-0567-2024

November 06, 2023

Class II

Product summary

Firm
Physio-Control, Inc.
Event
Event 93234
Status
Ongoing
Classification
Class II
Quantity
18,732
Official record key
device-enforcement:Z-0567-2024

Official wording

Reason: 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.

Code information: UDI-DI: 00883873940204, Adapters manufactured between 11/3/2021 - 4/24/2023

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.