Incisive CTRecalls & reported problems across all models

We found 2 models of Incisive CT by Philips Healthcare (Suzhou) Co., Ltd. in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2021 and Mar 26, 2026 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Intermittent Program or Algorithm Execution” (7 reports).

16 FDA recall records name at least one of these models by its device identifier, 13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Incisive CT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · 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 · names 2 of these models · Recall details · 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 · names 2 of these models · Recall details · 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-1872-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. 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 · Recall details · FDA record ↗

6. 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 · names 2 of these models · Recall details · FDA record ↗

7. 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 · Recall details · FDA record ↗

8. 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 · Recall details · FDA record ↗

9. 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-1622-2023 · Root cause: Software design · Recall details · FDA record ↗

10. 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 · Recall details · FDA record ↗

11. 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-1585-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

12. 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 · names 2 of these models · Recall details · FDA record ↗

13. 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 · names 2 of these models · Recall details · FDA record ↗

14. 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 · Recall details · FDA record ↗

15. 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 · Recall details · FDA record ↗

16. 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 · Recall details · FDA record ↗

Most reported Incisive CT problems

Incisive CT models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Incisive CT

  System, x-ray, tomography, computed
  13 recalls5 reports
• Incisive CT

  System, X-Ray, Tomography, Computed
  9 recalls20 reports

Recent Incisive CT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Mechanical Problem; No Fail-Safe Mechanism

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; IT WAS REPORTED THAT THE LONGITUDINAL TOOTHED BAR(FAIL-SAFE DEVICE) WAS NOTED TO BE INCORRECTLY INSTALLED UPON ARRIVAL. THERE IS NO ALLEGATION OF DEATH OR SERIOUS INJURY. HOWEVER, IT IS UNCERTAIN WHETHER THIS EVENT IS LIKELY TO RECUR AND CAUSE A SERIOUS INJURY DURING SERVICE. THEREFORE, 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 24696044 ↗
• 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 ↗
• MalfunctionMay 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HEAT EXCHANGER HAD BECOME DETACHED FROM ITS HOUSING, CAUSING DAMAGE TO OTHER INTERNAL COMPONENTS WITHIN THE GANTRY. HOWEVER, THE HEAT EXCHANGER BOX ITSELF REMAINED INTACT. THERE WAS NO REPORT OF HARM. HOWEVER, IF THIS ISSUE WAS TO RECUR, IT IS UNCERTAIN WHETHER IT IS LIKELY TO CAUSE A SERIOUS INJURY. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THIS ISSUE HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042148 ↗
• MalfunctionApr 9, 2025No Apparent Adverse Event; Program or Algorithm Execution Problem; No Apparent Adverse Event; Program or Algorithm Execution Problem

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; THE ISSUE REPORTED WAS THE SAVED IMAGE FROM THE SCAN CHANGES THE APPEARANCE OF A MEASUREMENT. THIS WAS MOVING THE MEASUREMENT OFF THE DESIRED AREA, CAUSING THE DOCTOR MARKED THE PATIENT IN THE WRONG PLACE. FORTUNATELY, THE DOCTOR NOTICED THIS ISSUE AND CORRECTED IT, THERE WAS NO HARM TO PATIENT. 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 INITIALLY DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS NOW COMPLETED THE INVESTIGATION OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21810996 ↗
• MalfunctionMar 11, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER ALLEGES THAT DURING A CONTRAST SCANNING PROCEDURE, A PATIENT BECAME UNSTABLE INSIDE THE GANTRY AND BEGAN KICKING. CONSEQUENTLY, BOTH GANTRY MYLAR RING AND GANTRY CONE WERE DAMAGED. THE INCIDENT OCCURRED WHILE THE GANTRY WAS ROTATING, FORTUNATELY, THERE WERE NO REPORTS OF HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONFIRMED THAT THE PATIENT HAD A NERVOUS ATTACK, AND A PATIENT STRAP WAS USED TO RESTRAINT THE PATIENT'S UPPER BODY. BASED ON THE INFORMATION AVAILABLE, THIS EVENT WAS A DIRECT RESULT OF THE PATIENT'S VOLUNTARY MOVEMENTS AND WAS NOT CAUSED BY THE DEVICE ITSELF. OUT OF AN ABUNDANCE OF CAUTION, THIS INCIDENT HAS BEEN DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS COMPLETED THE INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570163 ↗
• InjuryJan 24, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT HAS BEEN ASSESSED BASED ON THE PROVIDED INFORMATION. THE CUSTOMER REPORTED THAT, FOLLOWING THE SUCCESSFUL COMPLETION OF A SCAN, AS THE PATIENT WAS BEING REMOVED FROM THE SCANNER, THEY VOLUNTARILY LIFTED THEIR LEFT LEG/KNEE, CAUSING IT TO STRIKE THE MYLAR COVER OF THE GANTRY. THIS RESULTED IN DAMAGE TO THE COVER AND A KNEE LACERATION THAT NECESSITATED TWO SUTURES FOR THE PATIENT. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS APPROPRIATELY RESTRAINED USING PATIENT STRAPS. THE CLINICAL ASSESSMENT HAS DETERMINED THAT THE REQUIRED MEDICAL INTERVENTION (SUTURES) MEETS THE CRITERIA FOR A SERIOUS INJURY. HOWEVER, IT IS IMPORTANT TO NOTE THAT THE INJURY WAS A RESULT OF THE PATIENT'S VOLUNTARY MOVEMENT. THE INCIDENT WAS NOT CAUSED BY THE DEVICE OR ANY IMPROPER OR UNINTENDED USE OF IT. DESPITE THIS, UPON REVIEWING ALL AVAILABLE INFORMATION, THIS EVENT HAS BEEN VOLUNTARILY DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS COMPLETED THE INVESTIGATION OF THIS EVENT.

  Patient problems: Laceration(s)

  MAUDE report 21230750 ↗
• MalfunctionApr 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; IT WAS REPORTED THAT T202 , THE TRANSFORMER WAS LOOSE AND FELL DOWN INTO THE GANTRY WHILE DEVICE WAS IN USE WITH PATIENT ON COUCH. THE GANTRY MYLAR RING, GANTRY COVER AND CABLES WERE DAMAGED AS THE RESULT OF THIS EVENT. THERE WAS NO REPORT OF INJURY OR HARM. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT. PHILIPS HAS STARTED THE INVESTIGATION OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069009 ↗
• InjuryMar 14, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED; CUSTOMER REPORTED THAT DURING AN ANGIO-LOWER LIMB EXAM INVOLVING A SLIGHTLY OBESE PATIENT, AN ERROR HAS OCCURRED INDICATING THAT THE CTDIVOL EXCEEDS THE 250MGY LIMIT, AND THE REQUESTED ACQUISITION CANNOT BE PERFORMED DUE TO SYSTEM LIMITATIONS. CUSTOMER ADJUSTED THE PROTOCOL PARAMETERS, SPECIFICALLY DECREASED THE MAS AND SLOWING DOWN THE ROTATION TIME, HOWEVER, ERRORS PERSISTED. CUSTOMER REPORTS THAT THE PATIENT WAS IN ¿URGENT AND SERIOUS CONDITION¿ AND ¿THE PATIENT WAS TRAUMATIZED. PATIENT WAS THEN TRANSFERRED TO A DIFFERENT HOSPITAL TO COMPLETE THE EXAM. THE PATIENT IS CURRENTLY HOSPITALIZED PER DOCTOR¿S INSTRUCTION. NO OTHER CLINICAL INFORMATION IS AVAILABLE AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18900490 ↗
• 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 PATIENT WAS DETECTED AS A LATERAL RIGHT DECUBITUS BY CAMERA WHILE THE PATIENT WAS PLACED ON THE COUCH WITH PRONE FEET FIRST POSITION. THERE WAS NO PATIENT INJURY OR HARM REPORTED. HOWEVER, IIAC(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 17994082 ↗
• 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. THE CUSTOMER REPORTED THAT RIGHT AFTER THE PROTOCOL SELECTION AND BEFORE EXECUTING A SURVIEW SCAN, IT WAS FOUND THAT SYSTEM HAS RECOGNIZED THE PATIENT ORIENTATION INCORRECTLY. THERE WAS NO PATIENT INJURY OR HARM REPORTED, NO MISDIAGNOSIS 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 17994081 ↗
• 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 PATIENT POSITION WAS INCORRECTLY RECOGNIZED AS PRONE INSTEAD OF SUPINE. THERE WAS NO PATIENT INJURY OR HARM REPORTED, NO MISDIAGNOSIS HAS 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17994080 ↗
• 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 ↗
• 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 PATIENT WAS POSITIONED SUPINE HEADFIRST, BUT THE SYSTEM RECOGNIZED THE POSITION INCORRECTLY TO PRONE HEADFIRST. ISSUE WAS IDENTIFIED BY THE TECHNICIAN BEFORE THE ACQUISITION AND HAD THE POSITION MANUALLY CORRECTED AFTERWARDS, THE FOLLOWING SCAN WAS PERFORMED AND LABELED WITH CORRECT PATIENT POSITION/DIRECTION. THERE WAS NO PATIENT INJURY OR HARM REPORTED. 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 17993985 ↗
• 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 PATIENT ORIENTATION DETECTED BY CAMERA WAS NOT CORRECT AND INCORRECT ACQUISITION WAS MADE. ISSUE WAS IDENTIFIED AND A PATIENT RESCANNED WAS PERFORMED WITH CORRECT PATIENT POSITION/DIRECTION LABELLED. THERE WAS NO PATIENT INJURY OR HARM REPORTED. 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 17993981 ↗
• MalfunctionOct 12, 2023Intermittent Program or Algorithm Execution; Intermittent Program or Algorithm Execution

  THE CUSTOMER REPORTED WAS 6 PATIENT IMAGES WERE FOUND FLIPPED DUE TO PRECISE RECOGNITION ERROR AND THIS RECORD IS TO ADDRESS PATIENT#6. THE CUSTOMER REPORTED THAT A PATIENT WAS POSITIONED FOR A CT SCAN, THE PRECISE POSITION RECOGNITION FUNCTION HAS IDENTIFIED THE PATIENT IMAGES FLIPPED. THE OPERATOR RECOGNIZED THE ISSUE AND CORRECTED THE POSITION MANUALLY. THE FOLLOWING SCANS WAS PERFORMED WITH CORRECT PATIENT POSITION/DIRECTION. THERE WAS NO HARM REPORTED IN THIS RECORD. HOWEVER, BASED ON THE INTERNAL REVIEW OF THE COMPLAINT, THIS ONE HAS BEEN IDENTIFIED TO BE A REPEAT MALFUNCTION OF A PREVIOUS MDR REPORTABLE EVENT. THEREFORE, THIS EVENT IS CONSIDERED REPORTABLE. PHILIPS HAS COMPLETED THE INVESTIGATION OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918403 ↗

Other Philips Healthcare (Suzhou) Co., Ltd. products

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