FDA Medical Device Recalls (openFDA)
Physio-Control, Inc.: AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
- Recall number
- Z-0567-2024
- Recalling firm
- Physio-Control, Inc.
- Product
- AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
- Status
- Open, Classified
- Initiated
- 2023-11-06
- Posted
- 2023-12-15
- Terminated
- not on file
- 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.
- 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 RSRecall@stryker.com 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 RSRecall@stryker.com 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 medtechsup@stryker.com
- Quantity
- 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.
- Lot, serial or model codes
- UDI-DI: 00883873940204, Adapters manufactured between 11/3/2021 - 4/24/2023
- 510(k) numbers
- not on file
- PMA numbers
- ["P160026"]
- Product code
- MKJ
- Firm FEI
- 3015876
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28