Recall Z-2596-2025— Philips North America Llc

Name: FDA recall Z-2596-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-13

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2025-08-13. It names one FDA 510(k) clearance: K012009. Product: Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.. Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2025-08-13
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K012009 — MX8000 IDT CT SYSTEMMarconi Medical Systems, Inc.·cleared 2001-09-13

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

Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

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