FDA Medical Device Recalls (openFDA)
Physio-Control, Inc.: LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
- Recall number
- Z-0301-2024
- Recalling firm
- Physio-Control, Inc.
- Product
- LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
- Status
- Open, Classified
- Initiated
- 2023-09-29
- Posted
- 2023-11-14
- Terminated
- not on file
- Reason
- Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
- Root cause
- 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
- 4 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, NC, NJ, NY.
- Lot, serial or model codes
- UDI: 00883873871713/ Serial number: 44174756, 46013280, 46966395, 48149013
- 510(k) numbers
- not on file
- PMA numbers
- ["P160026"]
- Product code
- MKJ
- Firm FEI
- 3015876
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28