Z-0567-2024Class II

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

Name: Z-0567-2024 AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Creator: Physio-Control, Inc.
Published: 2023-11-06
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2023-11-06 / Open, Classified

FDA source

Physio-Control, Inc. began a recall of AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098 on 2023-11-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0567-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-06
Posted: 2023-12-15
Recalling firm: Physio Control, Inc.
Product: AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
FDA root cause: Component change control
Action: On 11/06/23, Recall and Field Safety Alert notices were sent to customers. The recall notices asked customers to do the following: 1) Complete and return business reply form by email to [email protected] 2) Firm recommends continued use. Follow the OI recommendations for daily inspection and testing according to the checklist provided in the Operating Instructions. a. The checklist includes disconnecting the defibrillator from the power adapter, turning the device on, and confirming that two batteries are installed and charged. Then, the defibrillator should be reconnected to the power adapter and users should confirm that the battery charging LED on the defibrillator is illuminated or flashing. b. If an ACPA is experiencing this failure mode, this will present to the user as the Aux Power Indicator on the LP15 flashing instead of solidly illuminating and the green LED strip on the ACPA flashing instead of solidly illuminating: 3) Please notify impacted customers that were shipped or may have been shipped this affected product by sharing this recall notification letter; Email Stryker at [email protected] with a list of customers who received/may have received this product and we can work with you on notifications to impacted customers. If you have any questions or feel that your ACPA may be experiencing issues, please contact Customer Service at 1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday - Friday or by email at [email protected]
Quantity in commerce: 18,732
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.
Product codes and lots: UDI-DI: 00883873940204, Adapters manufactured between 11/3/2021 - 4/24/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0567-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0567-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-15

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)