Brilliance iCTRecalls & reported problems across all models

We found 2 models of Brilliance iCT by Philips Medical Systems Nederland B.V. in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2017 and Sep 22, 2026 — classified as 3 injuries, 6 malfunctions.

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

8 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Brilliance iCT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · 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 · Recall details · 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 · Recall details · 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 · Recall details · 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 · Recall details · 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 · names 2 of these models · Recall details · 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 · Recall details · 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 · Recall details · FDA record ↗

Most reported Brilliance iCT problems

Brilliance iCT models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Brilliance iCT

  System, x-ray, tomography, computed
  8 recalls6 reports
• Brilliance iCT Brilliance iCT SP

  System, x-ray, tomography, computed
  1 recall3 reports

Recent Brilliance iCT adverse event reports

The 9 most recent reports across all models, 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 ↗
• MalfunctionMay 10, 2023Unintended System Motion; Unintended System Motion

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE CUSTOMER REPORTED THAT WHILE LOWERING THE CT COUCH, THE COUCH DESCENDED RAPIDLY AND WHEN IT REACHED THE LOWEST POINT THERE WAS A LOUD NOISE. THE SYSTEM WAS IN CLINICAL USE WITH PATIENT ON THE TABLE, HOWEVER THE PATIENT WAS NOT INJURED. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND DETERMINED THE BALL SCREW HAD FAILED. HE REPLACED THE BALL BEARING AND BALL SCREW AT THE SITE. THERE IS POTENTIAL OF SERIOUS INJURY IF THIS ISSUE WERE TO RECUR, THEREFORE THIS EVENT IS CONSIDERED REPORTABLE. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16905771 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE ISSUE REPORTED WAS THAT DURING ROUTINE PREVENTIVE MAINTENANCE (PM) WORK ON A BRILLIANCE ICT, THE PHILIPS FIELD SERVICE ENGINEER (FSE) SUSTAINED A COMPOUND FRACTURE OF THE LEFT PROXIMAL INDEX FINGER WHICH REQUIRED SURGERY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 12851856 ↗
• MalfunctionMay 8, 2018No Audible Alarm; Defective Component

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE CUSTOMER REPORTED THE INTERCOM SYSTEM WAS FAULTY. A PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED THE OPERATOR WAS NOT ABLE TO HEAR THE PATIENT AT ALL TIMES. IF THE OPERATOR IS UNABLE TO HEAR THE PATIENT DUE TO A FAILED COMPONENT, 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 7495055 ↗
• 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 ↗

Other Philips Medical Systems Nederland B.V. products

• Allura Xper FD19 models · 15,187 reports · 84 recalls
• Azurion22 models · 9,199 reports · 71 recalls
• Ingenia54 models · 479 reports · 138 recalls
• IntelliSpace Cardiovascular11 models · 439 reports · 3 recalls
• MR 7000 Series2 models · 4 reports · 11 recalls
• Dynamic Coronary Roadmap3 models · 10 reports · 9 recalls
• MR 5000 Series3 models · 11 reports · 8 recalls
• Zenition2 models · 101 reports · 5 recalls