Incisive CT (REF 728143)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838085015), received between Feb 11, 2021 and Nov 25, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

13 FDA recall records name this device's identifier, 10 still open.

11 other recalls cover devices cleared under the same FDA submission (K180015); they may or may not involve this specific model.

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 26, 2026Open, Classified

   Potential of failing to trigger clinical scan during Bolus Tracking.

   Z-2988-2026 · Root cause: Radiation Control for Health and Safety Act · FDA record ↗

2. Oct 29, 2025Open, Classified

   If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.

   Z-0881-2026 · Root cause: Under Investigation by firm · FDA record ↗

3. Sep 25, 2025Open, Classified

   Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axial scan with ORI (Dose Right index)/ DOM (Dose Modulation), the WED (Water Equivalent Diameter) value might set itself to zero, and this may lead to an insufficient dose setting after the surview. If operator misses the insufficient dose and the WED value in User Interface and continues with the subsequent helical/Axial scans, then the obtained images will be noisy due to low dose setting. Issue 3: Due to a software failure, the ECG wave file is not saved. As a result, the cardiac offline image reconstruction fails due to the missing ECG wave file, and the user might rescan the patient. Issue 4: This issue is software fault in which the patient orientation will be changed to NULL under specific random scenarios resulting in radiation being delivered from the wrong orientation (surview scan) or in the wrong position (clinical scan) and will generate incorrect and undiagnosable surview/clinical images. Patients may be rescanned for surview and/or clinical images. Issue 5: During scanning, the preview image display is not consistent, the images are not arriving at a fixed rate, skipping images from time to time during scanning. The obtained images might not support making the clinical diagnosis and the user might decide to re-scan the patient. Issue 6: If a user presses the left and middle/right mouse buttons together or afterwards in a short time, both commands are executed and an incorrect auto ROI is created. This ROI coordinates won t be assigned as the object is empty. As a result, the threshold of contrast level will not be reached in the UI and this will prevent the system from automatically triggering the subsequent clinical scan. There is potential safety risk identified for additionally tracker shots and/or rescan of a patient when the clinical scan is not triggered. This issue only affects the manual ROI process.

   Z-0375-2026 · Root cause: Under Investigation by firm · FDA record ↗

4. Apr 15, 2024Open, Classified

   Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive CT system, may become compromised, resulting in potential contact with other gantry components located within the Incisive CT system during rotation. Resulting in a fragment of a damaged component expelled at a low velocity

   Z-1871-2024 · Root cause: Under Investigation by firm · FDA record ↗

5. Dec 7, 2023Open, Classified

   If the Patient Interface Monitor (PIM) Cable is plugged/unplugged frequently as part of daily operation, the connector and wire may disconnect from the welding point, which may result in intermittent loss of the ECG signal. Loss of ECG signal may lead to the decision to rescan the patient or delay in diagnosis during a clinical emergency.

   Z-0719-2024 · Root cause: Component design/selection · FDA record ↗

6. Apr 25, 2023Open, Classified

   Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down

   Z-2258-2023 · Root cause: Under Investigation by firm · FDA record ↗

7. Apr 12, 2023Open, Classified

   Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required

   Z-1623-2023 · Root cause: Software design · FDA record ↗

8. Mar 20, 2023Open, Classified

   Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the Unload Pedal of the foot switch to perform the unload function may cause entrapment of the operator's foot and injury

   Z-1586-2023 · Root cause: Under Investigation by firm · FDA record ↗

9. Dec 23, 2022Open, Classified

   Multiple software issues which have the potential to lead to misdiagnosis due to image artifacts or incorrect image orientation labels, or the need for a CT rescan. These include: 1. Artifacts may occur on perfusion images, 2. Orientation label reversed in 2D images, 3. Auto voice does not work during the cardiac scan, 4. Auto voice and operators voice are too quiet, patient cant hear, 5. Not all of the images are reconstructed in some cases, 6. No image displayed on the console monitor after enabling CCT Single Scan, 7. Ring artifact appears in 32x0.625 collimation of bone scan when soft tissue view is selected, 8. A design defect where the error couch motion signal of couch firmware causes couch to identify current position as target position in next protocol, and 9. calcium scoring study split into separate series after loading to ISP.

   Z-0640-2024 · Root cause: Software design · FDA record ↗

10. Mar 29, 2022Completed

    Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.

    Z-0576-2024 · Root cause: Software design · FDA record ↗

11. Feb 24, 2021Terminated

    Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to its limit position.

    Z-1273-2021 · Root cause: Process control · FDA record ↗

12. Feb 22, 2021Terminated

    Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may tilt forward slowly, in a worst case, reaching to the tilt limit angle +31degrees

    Z-1265-2021 · Root cause: Process control · FDA record ↗

13. Dec 24, 2020Open, Classified

    Patient tabletop moved out to the home position during scan initialization, may cause operator/bystander staying by the rear of the table to collide with the moved tabletop and be injured

    Z-1507-2024 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THE ISSUE REPORTED WAS THAT A PATIENT WHO SUSTAINED A LACERATION ON THE LEG AFTER IT BECAME TRAPPED BETWEEN THE TABLE AND THE GANTRY WHILE THE TABLE WAS BEING MOVED. THE PATIENT WAS SEDATED AND INTUBATED AT THE TIME OF THE INCIDENT AND WAS BEING TREATED FOR GI BLEEDING. ADDITIONAL INFORMATION WAS RECEIVED AT A LATER TIME CONFIRMED THAT THE PATIENT HAD A LACERATION AROUND 5 INCHES LONG AND INTO THE MUSCLE. IT WAS UNABLE TO BE REPAIRED WITH SUTURES DUE TO THE SKIN BEING TOO DELICATE. BASED ON THE AVAILABLE INFORMATION, THIS DEVICE EVENT HAS BEEN CLASSIFIED AS A SERIOUS INJURY. THEREFORE, THIS EVENT HAS BEEN DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: Laceration(s)

  MAUDE report 23653241 ↗
• MalfunctionOct 24, 2023Intermittent Program or Algorithm Execution; Intermittent Program or Algorithm Execution

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. IT WAS REPORTED THAT SYSTEM HAS RECOGNIZED THE PATIENT POSITION FROM FACE UPWARD TO FACE DOWNWARD. ISSUE WAS IDENTIFIED BY THE USER AFTER THE SHOLE SCAN COMPLETION BUT BEFORE IMAGE DISTRIBUTION FOR DIAGNOSIS. THERE WAS NO ACTUAL INJURY OCCURRED. HOWEVER, IIA(ISSUE IMPACT ASSESSMENT) D001255537_REV_C WAS UPDATED WITH RISK ASSESSMENT RE-EVALUATED. AN INTERNAL RETROSPECTIVE REVIEW OF THE COMPLAINT HAS IDENTIFIED THIS COMPLAINT A SIMILAR MALFUNCTION OF A MDR EVENT WE HAVE REPORTED. THEREFORE, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. RISK EVALUATION CONCLUSION IN IIA: POH FOR S0 ¿ MISDIAGNOSIS IS ESTIMATED AT L3 - PROBABLE. POH FOR S1 ¿ MISDIAGNOSIS IS ESTIMATED AT L2 - REMOTE. POH FOR S2 ¿ MISDIAGNOSIS IS ESTIMATED AT L2 - REMOTE. POH FOR S3 ¿ MISDIAGNOSIS IS ESTIMATED AT L2 ¿ REMOTE. PHILIPS HAS COMPLETED THE INVESTIGATION OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994028 ↗
• MalfunctionApr 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE ISSUE REPORTED WAS DURING A PATIENT PROCEDURE, THE HEAT EXCHANGER CAME LOOSE/DETACHED WITHIN THE GANTRY CAUSING DAMAGE INTERNALLY. THERE WAS NO REPORT OF HARM. IF THIS ISSUE WERE TO RECUR WHERE THE HEAT EXCHANGER WERE TO COME LOOSE AND BE EXPELLED THROUGH THE GANTRY, THERE IS POTENTIAL FOR DEATH OR SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS EVENT IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16672449 ↗
• MalfunctionDec 22, 2022Use of Device Problem; Program or Algorithm Execution Failure; Use of Device Problem; Program or Algorithm Execution Failure

  THE ISSUE REPORTED WAS THE PREVIEW IMAGES FOR A PATIENT HEAD SCAN WERE FLIPPED; FACE UP POSITION TO FACE DOWN. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE FLIPPED/MISLABELED IMAGES WERE NOT INITIALLY RECOGNIZED WHICH RESULTED IN A MISDIAGNOSIS. AN ADDITIONAL SCAN WAS PERFORMED DURING A CLINICAL EXAMINATION OF THE PATIENT PRIOR TO SURGERY WHICH IDENTIFIED THAT THE IMAGES WERE FLIPPED/MISLABELED ON THE INITIAL SCAN. THE SURGERY WAS PERFORMED ON THE ACCURATE SIDE AND CORRECT MEDICAL TREATMENT WAS PROVIDED. THERE IS POTENTIAL FOR DEATH/SERIOUS INJURY IF THIS ISSUE WERE TO RECUR, THEREFORE THIS EVENT IS CONSIDERED REPORTABLE. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035044 ↗
• MalfunctionFeb 11, 2021Unintended System Motion; Unintended System Motion

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. PHILIPS SUZHOU FACTORY DETECTED AN ISSUE WITH INCISIVE CT SYSTEMS WHERE THE COUCH AND GANTRY CANT SELF-LOCK RESULTING IN THE COUCH TO DESCEND DOWN / THE GANTRY TO TILT AUTOMATICALLY AT A VERY SLOW SPEED TO ITS LIMIT POSITION OR STOP WHEN REACH A FORCE BALANCE POINT. THIS HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11315961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180015. One submission often covers many models, so check the product and lot details in each record.

• Z-1003-2026 · Dec 3, 2025 · Open, Classified
  Philips Incisive CT
• Z-0377-2026 · Sep 25, 2025 · Open, Classified
  Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
• Z-0376-2026 · Sep 25, 2025 · Open, Classified
  Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
• Z-2520-2023 · Aug 2, 2023 · Open, Classified
  Incisive CT, software version 5.0
• Z-2260-2023 · Apr 25, 2023 · Open, Classified
  Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148
• Z-2259-2023 · Apr 25, 2023 · Open, Classified
  Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
• Z-2261-2023 · Apr 25, 2023 · Open, Classified
  Incisive CT Plus-Computed Tomography X-Ray System Model: 728149
• Z-1622-2023 · Apr 12, 2023 · Open, Classified
  Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
• Z-1624-2023 · Apr 12, 2023 · Open, Classified
  Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
• Z-1625-2023 · Apr 12, 2023 · Open, Classified
  Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
• Z-1585-2023 · Mar 20, 2023 · Open, Classified
  Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814