Recall Z-1660-2025— Philips North America Llc

Name: FDA recall Z-1660-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-01

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2025-04-01. It names one FDA 510(k) clearance: K171850. Product: Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.. Reason: Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2025-04-01
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K171850 — Philips CT Big BorePhilips Medical Systems (Cleveland), Inc.·cleared 2017-11-09

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 Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

Reason for recall

Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

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