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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 15 Monitor/Defibrillator

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 Class 2 Device Recall LIFEPAK 15 Monitor/Defibrillatorsee related information
Date Initiated by FirmNovember 06, 2023
Date PostedDecember 15, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0567-2024
Recall Event ID 93234
PMA NumberP160026 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductAC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Code Information UDI-DI: 00883873940204, Adapters manufactured between 11/3/2021 - 4/24/2023
FEI Number 3015876
Recalling Firm/
Manufacturer		 Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information ContactJoyce Staggs
425-867-4597
Manufacturer 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 Determined
Cause 2		Component change control
ActionOn 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 in Commerce18,732
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MKJ
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