LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023

FDA device recall Z-0304-2024 · posted 2023-11-14 · Open, Classified

Recall details

Recalling firm

Physio-Control, Inc.

Reason for recall

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

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/

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MKJ

Quantity affected

1 unit

Distribution

US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.

Date initiated

2023-09-29

Date posted

2023-11-14

Location

Redmond, WA