Brilliance iCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838059474), received between Dec 8, 2017 and Sep 22, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (2 reports).

8 FDA recall records name this device's identifier, 5 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 7, 2026Open, Classified

   Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.

   Z-3040-2026 · Root cause: Radiation Control for Health and Safety Act · FDA record ↗

2. Jun 11, 2026Open, Classified

   The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

   Z-2650-2026 · Root cause: Radiation Control for Health and Safety Act · FDA record ↗

3. Jan 7, 2026Open, Classified

   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.

   Z-1315-2026 · Root cause: Process change control · FDA record ↗

4. Aug 13, 2025Open, Classified

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

   Z-2598-2025 · Root cause: Process control · FDA record ↗

5. Jun 8, 2021Terminated

   When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

   Z-2314-2021 · Root cause: Software design · FDA record ↗

6. May 1, 2021Open, Classified

   Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

   Z-1990-2021 · Root cause: Device Design · FDA record ↗

7. Nov 10, 2017Terminated

   Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.

   Z-0391-2018 · Root cause: Under Investigation by firm · FDA record ↗

8. Nov 10, 2017Terminated

   Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.

   Z-0388-2018 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Use of Device Problem

  This complaint has been evaluated based on the information provided. During servicing of the Brilliance iCT system, a Philips field service engineer sustained an injury to the left hand while cleaning the CT slip ring when the gantry was moved while the engineer¿s hand was positioned in a known pinch-point area. The event resulted in a laceration across the left index finger at the metacarpophalangeal joint, an approximately 0.5-inch laceration on the dorsal aspect of the index finger, a puncture wound to the index finger, and a crush/pinch injury to the left little finger. The employee initially received first-aid treatment consisting of wound cleaning and bandaging and was subsequently evaluated and treated in the emergency department. Medical treatment included placement of five sutures in the index finger. X-ray examination confirmed the absence of fractures. Subsequent evaluation by a hand specialist documented ongoing numbness and tingling in the left index and little fingers; however, the presence or extent of any permanent impairment could not be determined at the time of assessment.Based on the available information, this issue has been determined to be a reportable event.

  Patient problems: Laceration(s)

  MAUDE report 50856741 ↗
• InjurySep 18, 2026Arcing

  The customer reported that the gantry shut down during the arterial phase of a control scan following embolization, resulting in a 30-minute delay. The patient¿s condition had reportedly deteriorated during the waiting period, and the patient was transferred back to the ICU (Intensive Care Unit). The scan was subsequently completed several hours later on a different system.No intervention was required during the 30-minute waiting period in the Radiology department; however, it remains unknown whether treatment was required after the patient returned to the ICU. No permanent impairment was reported, and the patient has recovered.Based on the available information, this issue has been determined to be a reportable event.Philips has started an investigation into this complaint. We will file a follow-up eMDR at the completion of the investigation.

  Patient problems: Insufficient Information

  MAUDE report 50819028 ↗
• MalfunctionMar 29, 2018Device Inoperable

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. A PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THAT DURING PLANNED MAINTENANCE (PM), THE MICROPHONE WAS FOUND TO HAVE FAILED. THE FSE CONFIRMED THAT THE PATIENT COULD NOT BE HEARD BY THE OPERATOR DUE TO THIS FAILURE. IF THE OPERATOR IS UNABLE TO HEAR THE PATIENT DUE TO A FAILED MICROPHONE, THERE IS POTENTIAL FOR INJURY TO THE PATIENT. THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7380950 ↗
• MalfunctionMar 27, 2018Device Inoperable

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE CUSTOMER REPORTED THAT THE INTERCOM SYSTEM FAILED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE OPERATOR COULD NOT HEAR THE PATIENT AT ALL TIMES. IF THE OPERATOR IS UNABLE TO HEAR THE PATIENT DUE TO A FAILED MICROPHONE, THERE IS POTENTIAL FOR INJURY TO THE PATIENT. THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7373347 ↗
• MalfunctionJan 17, 2018No Audible Alarm

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE CUSTOMER REPORTED THAT THE GANTRY MICROPHONE FAILED AND THEREFORE, THE OPERATOR COULD NOT HEAR THE PATIENT. IF THE OPERATOR IS UNABLE TO HEAR THE PATIENT DUE TO A FAILED MICROPHONE, THERE IS POTENTIAL FOR INJURY TO THE PATIENT. THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION TO DETERMINE THE CAUSE OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7201709 ↗
• MalfunctionDec 8, 2017Signal Artifact/Noise; Degraded

  ENGINEERING ANALYSIS CONCLUDED THAT THIS EVENT HAS THE POTENTIAL TO RESULT IN IMAGE MISINTERPRETATION DUE TO AN ARTIFACT FROM A DEGRADED COMPENSATOR WITHIN THE COLLIMATOR. THEREFORE, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7102098 ↗