Brilliance iCT; Product Code (REF): 728306;

FDA device recall Z-1315-2026 · posted 2026-02-06 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

Action taken

On or about January 7, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. As a precaution, monitor the gantry for any unusual sounds or vibrations during operation. If unusual sounds are heard or vibrations are observed, immediately call your service contact. In the absence of unusual sounds or vibrations, you may continue to use your system(s) according to the intended use. 2. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) until Philips has inspected your system and has provided any correction, if needed. Ensure the letter is in a place likely to be seen and read. Actions planned by Philips: Philips will contact you to schedule a time for a Philips Field Service Engineer (FSE) to visit your site and to inspect the fasteners on your system (reference FCO72800845). If the inspection indicates that your system is affected, Philips will perform the correction to resolve the issue (reference FCO72800846)

Root cause

Process change control

Status

Open, Classified

Product code

JAK

Quantity affected

47 units

Distribution

Worldwide - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MA, MD, MN, NC, NY, OH, OR, PA, TX, VT, WA, WV and the countries of Australia, Austria, Bahrain,

Date initiated

2026-01-07

Date posted

2026-02-06

Location

Cambridge, MA

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