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LIFEPAK 15 monitor/defibrillator recallZ-0298-2024 · Physio-Control, Inc. · initiated Sep 29, 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

Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.

FDA root cause category: Under Investigation by firm

What the company is doing

On October 6, 2023, Stryker issued a "Urgent Medical Device Correction" Notification to affected consignees. Stryker ask consignees to take the following actions: 1. Please check your internal inventory to locate the affected product listed on the attached business reply form. 2. To confirm receipt of this Medical Device Notice and understanding of the provided information, please email the enclosed Business Reply Form (BRF) by October 31, 2023, to [email protected]. 3. Once the BRF is received, a Stryker Representative will contact you to arrange for corrective action on the device. There are no additional actions that users can and should take. 5. In the interim, Stryker recommends that you continue to use your LP15 v4 device. 6. Maintain awareness of this communication internally until all required actions have been completed within your facility. 7. Inform Stryker if any of the subject devices have been distributed to other organizations by contacting Stryker at: a. Device Tracking: [email protected] b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/

Recall details

Recall number
Z-0298-2024
Status
Open, Classified
Initiated by the company
Sep 29, 2023
Posted by the FDA
Nov 14, 2023
Recalling firm
Physio-Control, Inc.
Quantity
1 unit
Product code
MKJ
FDA submissions
P160026
Distribution
US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.

Product description

LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067

Code information (models, lots, serial numbers)

UDI: 00883873979358/ Serial number: 38166543

Devices named in this recall

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

Product lines

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 93233).

Sources and updates

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