Philips North America: Device Recall

Recall #Z-0166-2026 · 09/12/2025

Class II: Risk

Recall Details

Recall Number: Z-0166-2026
Classification: Class II
Product Type: Device
Recalling Firm: Philips North America
Status: Ongoing
Date Initiated: 09/12/2025
Location: Cambridge, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 29 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.

Product Description

Cardiac Workstation 7000; Model Number: 860441;

Distribution Pattern

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

Other Recalls by Philips North America

Class II: Risk 12/22/2025

A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Class II: Risk 12/03/2025

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Class II: Risk 12/03/2025

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

View all recalls by Philips North America →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.