Philips North America recalls Cardiac Workstation 5000

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

Cardiac Workstation 5000; Model Number: 860439;

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.

• FDA enforcement recordOfficial FDA database entry for Z-0165-2026
• FDA 510(k) clearance · K241556The device's official FDA premarket clearance record
• FDA device classification · DPSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.2340The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Philips North AmericaSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.