Brilliance CT Big BoreRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838059450), received between May 9, 2024 and May 9, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Noise, Audible” (1 report).

7 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 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-2597-2025 · Root cause: Process control · FDA record ↗

2. Apr 1, 2025Open, Classified

   Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.

   Z-1660-2025 · Root cause: Software design · FDA record ↗

3. Oct 9, 2023Open, Classified

   For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

   Z-0293-2024 · Root cause: Under Investigation by firm · FDA record ↗

4. Oct 9, 2023Open, Classified

   For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.

   Z-0294-2024 · Root cause: Under Investigation by firm · FDA record ↗

5. 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-1983-2021 · Root cause: Device Design · FDA record ↗

6. Mar 28, 2018Terminated

   A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

   Z-2273-2018 · Root cause: Other · FDA record ↗

7. Feb 23, 2017Terminated

   Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).

   Z-1493-2017 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2024No Apparent Adverse Event; Noise, Audible; No Apparent Adverse Event; Noise, Audible

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THIS ISSUE REPORTED WAS AN INTERVENTIONAL ONCOLOGIST WHO SPENDS EXTENDED PERIODS OF TIME IN THE BB CT ROOM HAS DEVELOPED TINNITUS. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THE COMPLAINT.

  Patient problems: Tinnitus

  MAUDE report 19283137 ↗