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AC Power Adapter for use with the LIFEPAK 15… recallZ-0567-2024 · Physio-Control, Inc. · initiated Nov 6, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Physio-Control, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Component change control

What the company is doing

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]

Recall details

Recall number
Z-0567-2024
Status
Open, Classified
Initiated by the company
Nov 6, 2023
Posted by the FDA
Dec 15, 2023
Recalling firm
Physio-Control, Inc.
Quantity
18,732
Product code
MKJ
FDA submissions
P160026
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 description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

27 devices cleared under P160026 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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