Philips North America: Medical Device Recall in 2025 - (Recall #: Z-0166-2026)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2025.
Data Source: FDA.
Product Description:
Cardiac Workstation 7000; Model Number: 860441;
Product Classification:
Class II
Date Initiated: September 12, 2025
Date Posted: October 22, 2025
Recall Number: Z-0166-2026
Event ID: 97612
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.
Status: Ongoing
Product Quantity: 29 units
Code Information:
Model Number: 860441; UDI-DI: 00884838094833; Serial Numbers: US42520284, US32520248, US32520244, US22520238, US22520221;
Distribution Pattern:
US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Voluntary or Mandated:
Voluntary: Firm initiated