Brilliance CT Brilliance 64Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838083325), received between Mar 10, 2020 and Oct 8, 2024 — classified as 1 death, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (5 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 7, 2026Class IIOpen, 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-3043-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

2. Jun 11, 2026Class IIOpen, 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 ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathOct 8, 2024Intermittent Communication Failure; Intermittent Communication Failure

  ON (B)(6) 2024, WITH THE INTENT TO REPLACE AN INDWELLING CHEST TUBE (DUE TO ONGOING EMPYEMA AND ITS FAILURE TO DRAIN) UNDER CT GUIDANCE, A FEMALE PATIENT WAS TRANSPORTED FROM THE INTENSIVE CARE UNIT (ICU) TO A CT ROOM ON HIGH FLOW OXYGEN. THE PATIENT'S INITIAL BLOOD PRESSURE AND HEART RATE WERE REPORTED AS WITHIN NORMAL LIMITS. THE PATIENT WAS RESPONSIVE; HOWEVER, SHE WAS CONFUSED AND WAS NOT ABLE TO CONSENT. DURING THE PROCEDURE, NO SEDATION WAS USED, ONLY FENTANYL FOR PAIN. THE PATIENT HAD THE INITIAL SURVIEW SCAN; HOWEVER, THE PROCEDURE COULD NOT START DUE TO AN IMAGING ISSUE . THE TEAM TRIED TO SEE IF THE IMAGING COULD WORK, BUT AFTER SEVERAL MINUTES, THE DECISION WAS MADE TO MOVE PATIENT TO ANOTHER SCANNER ACROSS THE HALL. THE PATIENT WAS THEN TRANSFERRED TO THE SCANNER ACROSS THE HALL (TAKING ONLY A COUPLE MINUTES) WHERE THE SURVIEW IMAGE WAS PERFORMED, AND THE CHEST TUBE PROCEDURE WAS STARTED. IT WAS REPORTED BY THE ATTENDING PHYSICIAN THAT PRIOR TO HER TRANSPORT TO THE SECOND SCANNER DURING TRANSPORT, AND UPON HER ARRIVAL TO THE SECONDARY SCANNER, VITAL SIGNS AND OXYGEN REQUIREMENTS WERE SIMILAR TO THOSE NOTED UPON HER ARRIVAL AT THE FIRST SCANNER. THE SECOND DEVICE WORKED

  Patient problems: Respiratory Insufficiency

  MAUDE report 20396353 ↗
• MalfunctionJun 2, 2023Unintended System Motion; Unintended System Motion

  THE ISSUE REPORTED WAS THAT WHILE MOVING THE PATIENT SUPPORT IN THE UP VERTICAL DIRECTION, THE COUCH DROPPED DOWN. THE SYSTEM WAS IN CLINICAL USE DURING THE EVENT; HOWEVER THERE WAS NO HARM REPORTED. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AND FOUND THE BALL SCREW WAS BROKEN. WE ARE CONSIDERING THIS EVENT REPORTABLE OUT OF ABUNDANCE OF CAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048715 ↗
• MalfunctionJun 2, 2023Unintended System Motion; Unintended System Motion

  THE ISSUE REPORTED WAS THAT WHILE MOVING THE PATIENT SUPPORT IN THE VERTICAL (UP) DIRECTION, THE COUCH AUTOMATICALLY DESCENDED (DOWN) TO ITS LOWEST POSITION. THE SYSTEM WAS IN CLINICAL USE DURING THE EVENT; HOWEVER, THERE WAS NO INJURY REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND FOUND THE BALL SCREW AND BEARING WERE BROKEN. WE ARE CONSIDERING THIS EVENT REPORTABLE OUT OF ABUNDANCE OF CAUTION. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048638 ↗
• MalfunctionMay 31, 2023Unintended System Motion; Unintended System Motion

  THE CUSTOMER REPORTED THAT WHILE PREPARING FOR A PATIENT SCAN, THERE WAS A LOUD NOISE AND THE CT COUCH SUDDENLY DROPPED DOWNWARD. THE PATIENT WAS NOT INJURED; THERE WAS NO REPORT OF HARM. PHILIPS FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AND FOUND THE BALL SCREW WAS FRACTURED. 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 17033165 ↗
• MalfunctionMay 11, 2023Unintended System Motion; Unintended System Motion

  REPORTING DETERMINATION: THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE CUSTOMER REPORTED THAT WHILE POSITIONING A PATIENT, THE CT COUCH SUDDENLY DROPPED DOWNWARD. THERE WAS NO REPORT OF HARM. THE PATIENT WAS MOVED TO ANOTHER CT SYSTEM WHERE THE EXAM WAS COMPLETED SUCCESSFULLY. 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 16916775 ↗
• MalfunctionJan 14, 2022Moisture or Humidity Problem; Unintended Electrical Shock; Moisture or Humidity Problem; Unintended Electrical Shock

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE ISSUE REPORTED WAS THAT WHEN THE OPERATOR WAS PRESSING THE GANTRY PANEL WITH THEIR FINGER TO MOVE THE TABLE, THE E-STOP OPENED AND THE OPERATOR ALLEGED THEY RECEIVED A SHOCK. THE EXTENT OF THE ALLEGED INJURY IS NOT KNOWN AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258838 ↗
• MalfunctionSep 2, 2021Crack; Crack

  THE ISSUE REPORTED WAS THAT DURING A PLANNED MAINTENANCE (PM) VISIT IT WAS DISCOVERED THAT ONE OF THE WELDS ON THE HEAT EXCHANGER HAD A CRACK IN THE SEAM. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, THIS EVENT HAS BEEN DETERMINED TO BE REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418847 ↗
• MalfunctionMar 27, 2020Unintended System Motion; Unintended System Motion

  REPORTING DETERMINATION: THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THAT THE COUCH HAD DESCENDED TO ITS LOWEST LIMIT UNCOMMANDED WITH A PATIENT ON IT. THE COUCH WAS ABOUT ONE METER OFF THE GROUND WHEN THIS OCCURRED. THE PATIENT LEFT THE CT DEPARTMENT WITH A COMPLAINT OF BACK PAIN AND WAS PENDING A DOCTOR ASSESSMENT. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT. THEREFORE, THIS COMPLAINT IS CONSIDERED TO BE A REPORTABLE EVENT TO THE REGULATORY AGENCY PER HA198-004-00 ADVERSE EVENT REPORTING PROCEDURE (CT/NM). THIS ISSUE IS NOT A REPORTABLE RADIATION EVENT PER HA198-005-00 CT/AMI RADIATION EVENT REPORTING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9887862 ↗
• InjuryMar 10, 2020Device Handling Problem; Device Handling Problem

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE ISSUE REPORTED WAS THAT THE CUSTOMER FINGER WAS PINCHED AND BROKEN WHILE OPERATING THE COUCH HORIZONTALLY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THEREFORE, THIS COMPLAINT IS CONSIDERED TO BE A REPORTABLE EVENT TO THE REGULATORY AGENCY PER (B)(4) ADVERSE EVENT REPORTING PROCEDURE (CT/NM). THIS ISSUE IS NOT A REPORTABLE RADIATION EVENT PER (B)(4) CT/AMI RADIATION EVENT REPORTING.

  Patient problems: Bone Fracture(s)

  MAUDE report 9811480 ↗