IQon Spectral CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884838059542), received between Apr 17, 2018 and Aug 27, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (1 report).

5 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. 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-2651-2026 · Root cause: Radiation Control for Health and Safety Act · FDA record ↗

2. Jan 7, 2026Open, Classified

   As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

   Z-1316-2026 · Root cause: Process change control · FDA record ↗

3. 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-2601-2025 · Root cause: Process control · FDA record ↗

4. 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-2317-2021 · Root cause: Software design · 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-1985-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2025Device Handling Problem; Device Handling Problem

  THE COMPLAINT WAS EVALUATED BASED ON THE INFORMATION PROVIDED. IT WAS REPORTED THAT DURING SLIP RING MAINTENANCE AS PART OF A PLANNED MAINTENANCE (PM) PROCEDURE ON AN IQON SPECTRAL CT SYSTEM, A PHILIPS FIELD SERVICE ENGINEER (FSE) SUSTAINED AN INJURY TO THE RIGHT INDEX FINGER. WHILE INSTALLING THE POWER BRUSH, THE FSE INADVERTENTLY PLACED HIS FINGER IN A PINCH POINT AREA, RESULTING IN THE FINGER BEING PINCHED. UPON RECOGNITION OF THE INJURY, THE FSE WAS ESCORTED TO THE EMERGENCY ROOM FOR MEDICAL CARE. THE SURGICAL TEAM CLEANED THE WOUND AND APPLIED SIX SUTURES. THE FSE RECEIVED AN ANTI-TETANUS VACCINE IN BOTH ARMS, FOLLOWED BY ORAL ANTIBIOTICS AND PAIN MEDICATION. THE IQON SPECTRAL CT PLANNED MAINTENANCE MANUAL PROVIDES DETAILED INSTRUCTIONS, INCLUDING PHOTOGRAPHS, TO PREVENT FINGER PINCHING DURING SLIP RING MAINTENANCE. THE INJURY OCCURRED DUE TO AN ERROR BY THE FSE, WHO INADVERTENTLY PLACED HIS HAND IN THE RISK AREA DESPITE EXISTING PROCEDURAL SAFEGUARDS. FAILURE TO FULLY ADHERE TO THE SAFETY PROTOCOL AND MANUAL INSTRUCTIONS CONTRIBUTED TO THE INCIDENT. BASED ON THE INVESTIGATION, THE EVENT IS CLASSIFIED AS USER ERROR. BASED ON THE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO B

  Patient problems: Crushing Injury

  MAUDE report 22909039 ↗
• InjuryJul 17, 2025Poor Quality Image; Insufficient Device Problem Information; Poor Quality Image; Insufficient Device Problem Information

  THE ISSUE REPORTED INVOLVED A HYPERDENSE BAND ARTIFACT THAT DISPLAYED ON THE MYOCARDIUM WALL DURING THE LATE ENHANCEMENT PHASE OF A CARDIAC PROCEDURE. THIS ARTIFACT CONTRIBUTED TO A DIAGNOSIS OF MYOCARDITIS. SUBSEQUENT IMAGING PERFORMED USING MAGNETIC RESONANCE IMAGING (MRI) INDICATED THAT THE PATIENT MAY HAVE RECEIVED INCORRECT DRUG TREATMENT DUE TO THE INITIAL (ALLEGED) MISDIAGNOSIS. NO ADDITIONAL CLINICAL DETAILS OR MEDICAL INTERVENTIONS WERE REPORTED. BASED ON THE LIMITED INFORMATION AVAILABLE AT THE TIME OF THIS REVIEW, THE EVENT IS CONSIDERED A REPORTABLE EVENT.

  Patient problems: Insufficient Information; Myocarditis

  MAUDE report 22534499 ↗
• MalfunctionMay 24, 2023Unintended System Motion; Unintended System Motion

  THE ISSUE REPORTED WAS DURING PATIENT PREPARATION WHILE MOVING THE TABLE UP IN THE VERTICAL DIRECTION, THE TABLE DESCENDED RAPIDLY DOWN AND WHEN IT REACHED ITS LOWEST POINT THERE WAS A LOUD NOISE. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AND FOUND THE BALLSCREW WAS BROKEN WHICH CAUSED THE TABLE TO DESCEND. THERE WAS NO HARM TO PATIENT OR OPERATOR AND NO MEDICAL INTERVENTION WAS NECESSARY AS A RESULT. WE ARE CONSIDERING THIS EVENT REPORTABLE OUT OF ABUNDANCE OF CAUTION. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16992227 ↗
• MalfunctionMay 23, 2023Program or Algorithm Execution Problem; Program or Algorithm Execution Problem

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS PUNCTATE HYPERDENSITIES DISPLAYED ON BRAIN MONOE 190KV DATASETS AND RESULTED IN A CT RESCAN TO DETERMINE ARTIFACT VS PATHOLOGY. THERE WAS NO ACTUAL HARM REPORTED ASSOCIATED WITH THIS COMPLAINT. BASED ON THE AVAILABLE INFORMATION, IT IS UNKNOWN IF THE REPORTED EVENT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. THEREFORE, THIS EVENT IS BEING CONSERVATIVELY REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983998 ↗
• MalfunctionApr 17, 2023Device 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 THE BED UNINTENTIONALLY LOWERED DURING A PATIENT PROCEDURE AND PULLED OUT THE PATIENT'S INTRAVENOUS (IV) DRIP. THIS CAUSED THE IV SITE TO BLEED. BASED ON THE INFORMATION PROVIDED, THIS EVENT DOES NOT MEET THE CRITERIA FOR A SERIOUS INJURY. IT WAS INDICATED THAT THERE WAS NO PATIENT EFFECT DUE TO THIS EVENT. BLEEDING FROM AN IV SITE IS COMMON AND/OR MINIMAL WHEN AN IV IS REMOVED FROM THE ACCESS SITE, AND MAY BE TREATED WITH APPLIED PRESSURE AND A BAND-AID. BASED ON THE AVAILABLE INFORMATION, IT IS UNKNOWN IF THE REPORTED EVENT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. THEREFORE, THIS EVENT IS BEING REPORTED CONSERVATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16758705 ↗
• MalfunctionApr 1, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  THE COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE ISSUE REPORTED WAS THAT THE CUSTOMER ENTERED THE PATIENT WEIGHT IN POUNDS, BUT THE P3T (PERSONALIZED PATIENT PROTOCOL) CALCULATION FOR THE REQUIRED CONTRAST AMOUNT WAS GIVEN FOR THE PATIENT WEIGHT IN KILOGRAMS, DOUBLING THE CONTRAST DOSE. 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 11602878 ↗
• MalfunctionApr 17, 2018No Audible Alarm

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. THE CUSTOMER REPORTED THE OPERATOR COULD NOT HEAR THE PATIENT FROM THE IMAGING ROOM. IF THE OPERATOR IS UNABLE TO HEAR THE PATIENT DUE TO A FAILED MICROPHONE, 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 7437168 ↗