Home / Recalls / Philips North America / Z-0165-2026

Z-0165-2026 Class II Ongoing

Recalled by Philips North America — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
October 22, 2025
Initiation Date
September 12, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28 units

Product Description

Cardiac Workstation 5000; Model Number: 860439;

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.

Distribution Pattern

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

Code Information

Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers:

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  • Z-1317-2026 Class II — Spectral CT; Product Code (REF): 728333; (January 7, 2026)
  • Z-1156-2026 Class II — Patient Information Center iX; Software Version Number: 4.5.0 (December 22, 2025)
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  • Z-1204-2026 Class II — Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR syst (December 3, 2025)