LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Recall
- Recall Number
- Z-0299-2024
- Event Number
- 93233
- Firm
- Physio-Control, Inc.
- FEI Number
- 3015876
- Product Code
- MKJ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 29, 2023
- Posted
- November 14, 2023
- Address
- 11811 Willows Rd Ne, Redmond, WA, 98052-2003
Description
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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/
US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
5 units