—#216113

Product

Cardiac Workstation 7000; Model Number: 860441;

FDA product code: DPS — Electrocardiograph
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K241556
Affected lot / code info: Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, IA, TN, TX, VA.

Timeline

Recall initiated: 2025-09-12
Posted by FDA: 2025-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216113. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.