Cardiac Workstation 7000; Model Number: 860441;
FDA Recall Z-0166-2026 · Posted 2025-10-16
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Recalling FirmPhilips North America
Recall StatusOpen, Classified
Product CodeDPS
Date Initiated2025-09-12
Product Quantity29 units
Reason for Recall
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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