Ingenuity CT (REF 728326)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838059511), received between Aug 12, 2020 and May 31, 2023 — classified as 3 malfunctions.

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

3 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. 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 ↗

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 31, 2023Unintended System Motion; Unintended System Motion

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE CUSTOMER REPORTED THAT WHILE RAISING THE COUCH WITH PATIENT ON TABLE, THE COUCH SUDDENLY DROPPED TO THE FLOOR. PHILIPS FIELD SERVICE ENGINEER(FSE) INSPECTED SYSTEM AND IDENTIFIED THAT COUCH BALL SCREW WAS BROKEN. FSE REPLACED BOTH BALL BEARING AND BALL SCREW, SYSTEM WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE AFTER PARTS REPLACEMENT. THERE WAS NO REPORT OF HARM. WE CONSIDERED THIS EVENT REPORTABLE OUT OF ABUNDANCE OF CAUTION. PHILIPS HAS NOW COMPLETED THE INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17033634 ↗
• MalfunctionJun 16, 2022Packaging Problem; Packaging Problem

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THAT IMPROPER PACKING FOR APM/CPM THAT WAS SENT TO THE SERVICE ENGINEER FOR REPLACEMENT. ENGINEERING INITIAL REVIEW OF THE EVENT HAS DETERMINED THE RISK IS UNACCEPTABLE. THERE IS POTENTIAL OF HARM. THIS EVENT IS CURRENTLY UNDER INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713030 ↗
• MalfunctionAug 12, 2020Patient Data Problem; Patient Data Problem

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE ISSUE REPORTED WAS THAT DURING A CT GUIDED PUNCTURE, NEWLY CREATED CT IMAGES WERE NOT UPDATED AFTER THE MESSAGE "VIEWER MEMORY FULL" WAS DISPLAYED ON THE CONSOLE. THIS RESULTED IN THE PATIENT'S PORTAL VEIN WAS INADVERTENTLY PUNCTURED. THE PATIENT WAS TRANSFERRED TO ANOTHER CT SYSTEM TO EVALUATE POTENTIAL INJURY(INTERNAL BLEEDING) AS A RESULT OF THE PORTAL VEIN PUNCTURE. PATIENT OUTCOME IS UNKNOWN AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 10399367 ↗