—#215654

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009
Affected lot / code info: 1. Model Number: 728240; UDI-DI: N/A; Serial Number: 6022. 2. Model Number: 728246; UDI-DI: N/A; Serial Numbers: 5029, 5698, 5834, 6272, 6313, 5307, 5305, 50129, 5286, 50017, 5388, 5424, 5422, 5515, 5497, 5584, 5668, 5624, 5771, 5814, 5872, 5907, 5900, 5928, 5869, 5939, 5944, 5993, 6137, 5411, 6160, 6153, 5504, 6182, 6199, 6209, 6219, 6271, 6302, 6330, 6357, 6358, 6369, 6405, 6343, 6410, 6558, 6490, 6635, 6532, 6590, 6547, 6669, 6691, 6563, 6756, 6755, 6738, 3578, 6776, 260046, 260074, 6752, 50219, 50028, 5412, 5839. 3. Model Number: 728256; UDI-DI: N/A; Serial Numbers: 30117, 3290, 3347, 3664, 3499.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

Philips Medical notified consignees on about 08/11/2025 via letter. Consignees were instructed that they could continue using the affected systems accordance with the intended use and by following the recommendation: Observe the warning listed in Instructions for Use (IFU) and make sure that the patient is strapped securely to avoid dangling of the hands. Ensure that the patient is placed securely on the patient table and is not in danger of falling. Additionally, consignees were instructed to complete and return the provided response form, to circulate Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue and retain this letter with your system(s) until your system is inspected and corrected if necessary. Philips will contact consignees to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and to inspect the affected system (FCO 72800832) and correct the system if necessary (FCO 72800833).

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

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.

Timeline

Recall initiated: 2025-08-13
Posted by FDA: 2025-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215654. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.