LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
- Company
- Physio Control, Inc.
- Recall Initiated
- September 29, 2023
- Posted
- November 14, 2023
- Recall Number
- Z-0305-2024
- Quantity
- 2 units
- Firm Location
- Redmond, WA
Reason for Recall
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Distribution
US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
Lot / Code Info
UDI: 00883873871669/ Serial number: 48433670 and 48744028
Root Cause
Under Investigation by firm
Action Taken
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/