FDA Medical Device Recalls (openFDA)
Philips North America: Cardiac Workstation 5000; Model Number: 860439;
- Recall number
- Z-0165-2026
- Recalling firm
- Philips North America
- Product
- Cardiac Workstation 5000; Model Number: 860439;
- Status
- Open, Classified
- Initiated
- 2025-09-12
- Posted
- 2025-10-16
- Terminated
- not on file
- Reason
- Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
- Root cause
- Process control
- Action
- On September 12, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Share this communication with all clinical staff to review and undedrstand. Please this letter with the device. Pass the notice along to all those who need to be aware within the organization or to any organization where affected devices were transferred. Ensure technical solution established by Philips is implemented as soon as available within the timeframe communicated by Philips. In case any device cannot be corrected, inform Philips of the reason why the Technical Solution could not be implemented. Action By Philips: A Philips representative will contact customers to arrange a replacement of the device's hardware on affected devices with the pinched power module wire within the housing of the Cardiac Workstation.
- Quantity
- 28 units
- Distribution
- US Nationwide distribution in the states of CA, IA, TN, TX, VA.
- Lot, serial or model codes
- Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers:
- 510(k) numbers
- ["K241556"]
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 3006648320
- Firm city
- Cambridge
- Firm state
- MA
- 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