Big Bore RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838095168), received between Jan 25, 2024 and Jan 25, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

4 FDA recall records name this device's identifier, 4 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-0292-2024 · Root cause: Under Investigation by firm · FDA record ↗

4. 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 ↗

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.

• MalfunctionJan 25, 2024Insufficient Device Problem Information; Program or Algorithm Execution Problem; Insufficient Device Problem Information; Program or Algorithm Execution Problem

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. IT WAS REPORTED THAT DURING THE PHILIPS INTERNAL TESTING PROCESS, IT WAS FOUND THAT THE CT SERIES RECONSTRUCTED WITH A X OR Y RECONSTRUCTION OFFSET PER DICOM PRIVATE TAG (01F1,100C), WHICH CAN BE USED WITHIN TUMOR LOC TO TRANSMIT INVALID ABSOLUTE MARKING COORDINATES TO A LASER MARKING SYSTEM. THESE INVALID COORDINATES MIGHT RESULT IN AN INCORRECT TREATMENT LOCATION ON THE PATIENT¿S SKIN. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED THE INVESTIGATION OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585099 ↗