MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. IQON SPECTRAL CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	IQON SPECTRAL CT
Medical Device Problem Codes	Poor Quality Image (1408); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Myocarditis (2470); Insufficient Information (4580)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Philips has started an investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: (b)(4).
Event or Problem Description
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.
Additional Manufacturer Narrative
Philips has investigated the reported complaint involving a hyperdense band artifact observed on the myocardium wall in patient images on an iqon spectral system.Multiple attempts were made to obtain relevant clinical information regarding the patient and any medical interventions performed; however, the customer did not respond to these requests.An evaluation of the dicom images confirmed that the hyperdense artifact was a motion enhanced cone beam artifact, caused by cardiac or anatomical motion occurring during image acquisition.This results in apparent enhancement within the reconstructed images.While no definitive workaround exists, artifact occurrence may be minimized by selecting an alternate cardiac phase with reduced motion.

• Brand Name: IQON SPECTRAL CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: john maga ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 22534499
• Report Number: 3015777306-2025-000007
• Device Sequence Number: 7409972
• Product Code: JAK
• UDI-Device Identifier: 00884838059542
• UDI-Public: (01)00884838059542
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IQON SPECTRAL CT
• Device Catalogue Number: 728332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown