Recall Z-0165-2026— Philips North America

Name: FDA recall Z-0165-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-12

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2025-09-12. It names one FDA 510(k) clearance: K241556. Product: Cardiac Workstation 5000; Model Number: 860439;. Reason: Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2025-09-12
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000)Philips Medizin Systeme Böblingen GmbH·cleared 2024-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.