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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/Defibrillator see related information
Date Initiated by Firm September 29, 2023
Date Posted November 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-0299-2024
Recall Event ID 93233
PMA Number P160026 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Code Information UDI: 00883873911648/ Serial number: 40644322 40644323 40644331 42221204 42934131
Recalling Firm/
Manufacturer		 Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact Joyce Staggs
425-867-4597
Manufacturer Reason
for Recall		 Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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 RSRecall@Stryker.com. 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: rsdevicetracking@stryker.com b. Website: https://www.strykeremergencycare.com/service-support-overview/device-registration/
Quantity in Commerce 5 units
Distribution US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
Total Product Life Cycle TPLC 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 Database PMAs with Product Code = MKJ and Original Applicant = Physio-Control. Inc.
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