Brilliance iCT Brilliance iCT SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838059481), received between May 8, 2018 and May 10, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K250648); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 1, 2021Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K250648. One submission often covers many models, so check the product and lot details in each record.

• Z-3040-2026 · Aug 7, 2026 · Open, Classified
  Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
• Z-2650-2026 · Jun 11, 2026 · Open, Classified
  Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
• Z-1315-2026 · Jan 7, 2026 · Open, Classified
  Brilliance iCT; Product Code (REF): 728306;