Philips North America Llc: Device Recall

Recall #Z-2597-2025 · 08/13/2025

Class II: Risk

Recall Details

Recall Number
Z-2597-2025
Classification
Class II
Product Type
Device
Recalling Firm
Philips North America Llc
Status
Ongoing
Date Initiated
08/13/2025
Location
Cambridge, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33 units

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.

Product Description

Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Mauritius, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Vietnam.

Other Recalls by Philips North America Llc

View all recalls by Philips North America Llc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.