Ingenuity CT (REF 728321)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838059498), received between Sep 1, 2022 and Aug 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

5 FDA recall records name this device's identifier, 3 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. 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-2652-2026 · Root cause: Radiation Control for Health and Safety Act · FDA record ↗

2. 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-2600-2025 · Root cause: Process control · FDA record ↗

3. 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-2315-2021 · Root cause: Software design · 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-1984-2021 · Root cause: Device Design · FDA record ↗

5. 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-2274-2018 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE INTERNAL RING COVER CAME LOOSE FROM A DAMAGED ROTATING INTERNAL COMPONENT AND CAUSED A PATIENT TO EXPERIENCE A SUPERFICIAL CUT TO THEIR LEFT ELBOW WITH SLIGHT BLEEDING. THE CUT WAS TREATED WITH A BANDAGE. PATIENT OUTCOME IS LISTED AS A BRUISE EXPECTED TO FULLY HEAL, NO PAIN AND FULL FUNCTIONALITY OF THE ELBOW/ARM. THEREFORE, THE REPORTED HARM DOES NOT MEET CRITERIA FOR SERIOUS INJURY. HOWEVER, IT IS UNCERTAIN WHETHER THIS EVENT IS LIKELY TO RECUR AND CAUSE A SERIOUS INJURY. THEREFORE, BASED ON THE AVAILABLE INFORMATION THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20044338 ↗
• MalfunctionSep 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS 5 OF 5 FASTENERS SECURING THE CT COUCH TO THE FLOOR WERE DISLODGED AND THAT THERE IS POTENTIAL FOR THE COUCH TO TIP. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME. BASED ON INFORMATION KNOWN AT THIS TIME, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THE ISSUE IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15334262 ↗