Philips North America: Medical Device Recall in 2025 - (Recall #: Z-0165-2026)

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 5000; Model Number: 860439;

Product Classification:

Class II

Date Initiated: September 12, 2025

Date Posted: October 22, 2025

Recall Number: Z-0165-2026

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: 28 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated