Ingenuity CT (REF 728323)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838059504), received between Dec 21, 2017 and Dec 11, 2025 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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-2275-2018 · Root cause: Other · 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.

• InjuryDec 11, 2025Crack; Crack

  THE CUSTOMER REPORTED THAT A TECHNICIAN SUSTAINED A MINOR CUT WHILE WIPING DOWN THE MYLAR RING COVER ON AN INGENUITY CT SYSTEM. ADDITIONAL INFORMATION CONFIRMED THAT THE TECHNICIAN WAS CLEANING BLOOD FROM THE SCANNER WHEN THEY SUSTAINED A SMALL PERCUTANEOUS PUNCTURE FROM THE BROKEN MYLAR. IT WAS CONFIRMED THAT THE EXPOSURE INVOLVED BLOOD POSITIVE FOR HEPATITIS C. AN ATTEMPT WAS MADE TO OBTAIN THE TECHNICIAN¿S POST-EXPOSURE RESULTS; HOWEVER, THE INFORMATION PROVIDED WAS THAT THE RESULTS WERE "POSITIVE," WITHOUT CLARIFICATION AS TO WHETHER THIS REFERRED TO THE SOURCE BLOOD ON THE MYLAR RING OR THE TECHNICIAN¿S OWN TEST RESULTS. DUE TO THE LACK OF CLARITY REGARDING THE TEST OUTCOME, THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY.

  Patient problems: Hepatitis; Laceration(s)

  MAUDE report 23778729 ↗
• InjuryDec 9, 2025Crack; Crack

  THE CUSTOMER REPORTED THAT A TECHNICIAN SUSTAINED A MINOR CUT WHILE WIPING DOWN THE MYLAR RING COVER ON AN INGENUITY CT SYSTEM. ADDITIONAL INFORMATION INDICATED THAT THE TECHNICIAN WAS CLEANING BLOOD FROM THE SCANNER WHEN THEY SUSTAINED A SMALL PERCUTANEOUS PUNCTURE FROM THE BROKEN MYLAR. IT WAS CONFIRMED THAT THE EXPOSURE INVOLVED BLOOD POSITIVE FOR HEPATITIS C. AN ATTEMPT WAS MADE TO OBTAIN THE TECHNICIAN¿S POST-EXPOSURE RESULTS; HOWEVER, THE INFORMATION PROVIDED WAS THAT THE RESULTS WERE ¿POSITIVE," WITHOUT CLARIFICATION AS TO WHETHER THIS REFERRED TO THE SOURCE BLOOD ON THE MYLAR RING OR THE TECHNICIAN¿S OWN TEST RESULTS. DUE TO THE LACK OF CLARITY REGARDING THE TEST OUTCOME, THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY.

  Patient problems: Hepatitis; Laceration(s)

  MAUDE report 23760867 ↗
• InjuryNov 13, 2025Environmental Particulates; Insufficient Device Problem Information; Environmental Particulates; Insufficient Device Problem Information

  PHILIPS RECEIVED A REPORT INDICATING THAT DURING AN INTERVENTIONAL CEMENTOPLASTY PROCEDURE, THE CT SYSTEM INTERMITTENTLY GENERATED AN ERROR MESSAGE, INTERRUPTING THE SCAN. DURING THE PROCEDURE, THE ERROR CAUSED THE SYSTEM TO CLOSE AND RESTART THE EXAMINATION, RESULTING IN A DELAY IN IMAGE ACQUISITION. DUE TO THE INTERRUPTION, A PORTION OF THE INJECTED CEMENT COULD NOT BE ADEQUATELY VISUALIZED AND SUBSEQUENTLY MIGRATED INTO THE PATIENT¿S INFERIOR VENA CAVA (IVC).

  Patient problems: Insufficient Information; Unspecified Vascular Problem

  MAUDE report 23549881 ↗
• InjuryAug 1, 2023Lack of Maintenance Documentation or Guidelines; Adverse Event Without Identified Device or Use Problem; Lack of Maintenance Documentation or Guidelines; Adverse Event Without Identified Device or Use Problem

  REPORTING DETERMINATION: THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS AN ALLEGATION OF SERIOUS INJURY. THIS ISSUE REPORTED WAS A FIELD SERVICE ENGINEER INJURED HIS BACK DURING REPLACEMENT OF THE X-RAY TUBE. FSE WAS DIAGNOSED WITH LUMBAR FASCITIS AND FLURBIPROFEN WAS PRESCRIBED AND REST FOR A WEEK. FSE WAS RECOVERED AND HAS BEEN RETURNED TO WORK. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: Fasciitis

  MAUDE report 17439160 ↗
• MalfunctionMay 16, 2023Unintended System Motion; Unintended System Motion

  REPORTING DETERMINATION: THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE CUSTOMER REPORTED SYSTEM MADE A VERY LOUD NOISE AND THEN TABLE DROPPED FROM RAISED POSITION FOR APPROXIMATELY 4 INCHES WHEN PATIENT GOT ON THE TABLE. THERE WAS NO REPORT OF HARM. THE PATIENT WENT TO A DIFFERENT FACILITY (HOSPITAL SITE) TO COMPLETE STUDY. PHILIPS FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AND CONFIRMED THAT THE BALL SCREW AND BEARINGS HAD FAILED. THE COUCH WAS REPLACED AT THE CUSTOMER SITE AND DEVICE WAS RETURNED TO CLINICAL USE AFTER THE SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937719 ↗
• DeathOct 14, 2021No Device Output; Failure to Calibrate; No Device Output; Failure to Calibrate

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE ISSUE REPORTED WAS THAT DURING A HEAD/ NECK CT ANGIO EXAM, THE SYSTEM HAD AN ERROR AND WOULD NOT EXPOSE. THE CUSTOMER STATED THEY STOPPED THE PATIENT SCAN. THE CUSTOMER HAS ALLEGED THAT THIS RESULTED IN A DELAYED RESCUE RESULTING IN THE PATIENT'S DEATH APPROXIMATELY 20 DAYS LATER. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT AND IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12632486 ↗
• InjuryAug 23, 2021Device Handling Problem; Device Handling Problem

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE ISSUE REPORTED WAS THAT WHILE POSITIONING AN UNCONSCIOUS PATIENT, THE PATIENT'S ARM WAS NOT SECURED AND BUMPED AGAINST THE GANTRY MYLAR RING. THIS LED TO THE MYLAR RING BEING DAMAGED CAUSING A LACERATION TO PATIENT'S ARM INJURY WHICH REQUIRED STITCHES. THERE WAS NO MALFUNCTION OF THE SYSTEM; IT IS WORKING AS SPECIFIED. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: Laceration(s)

  MAUDE report 12357304 ↗
• MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THAT GANTRY MYLAR RING BROKE AND MADE CONTACT WITH THE PATIENT IN THE FACE AND ELBOW. BASED ON THE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676277 ↗
• MalfunctionDec 21, 2017Noise, Audible

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE CUSTOMER REPORTED THAT THERE WAS NOISE FROM THE CT BOX SPEAKER DUE TO GANTRY ELECTRONICS/FAN SOUNDS WITHOUT ANY INPUT FROM THE MICROPHONE; THEREFORE, THE SPEAKER VOLUME WAS TURNED DOWN. IF THE OPERATOR IS UNABLE TO HEAR THE PATIENT DUE TO THE VOLUME BEING TURNED DOWN TO A MINIMUM, THERE IS POTENTIAL FOR INJURY TO THE PATIENT. THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139620 ↗