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

Model Number	SPECTRAL CT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not completed our investigation of this event.Upon completion, we will submit a follow-up emdr report.
Event or Problem Description
On 27-nov-2025, a field service engineer (fse) reported that damage to a torque seal during planned maintenance (pm) on a spectral ct 7500 system ((b)(6) product number 72833) at asahichuo general hospital in japan.The system was not in clinical use at the time and there was no harm to the user, a patient or bystanders.During inspection, 13 of the 15 screws inspected were found to be correctly torqued to design specification.Engineering found the remaining 2 screw heads were under torqued (12nm), moved approximately 20-30 degrees and were not correctly tightened to design torque.The screws were corrected by re-applying the correct design torque during the torque check process.As a result, an issue impact assessment was completed on 10-dec-2025 to assess the risk for this issue and indicated a remote probability of resulting in serious adverse health consequences but not likely to result in medically reversible or transient adverse health consequences.Philips has started an investigation into this event.
Additional Manufacturer Narrative
Philips previously reported damage to a torque seal during planned maintenance (pm) on a spectral ct 7500 device.The system was not in use at this time and no report of patient harm or injury.During inspection, the field service engineer found 13 of the 15 screws inspected were found to be correctly torqued to design specification.Engineering found the remaining 2 screw heads were under torqued (12nm), moved approximately 20-30 degrees and were not correctly tightened to design torque.The screws were corrected by re-applying the correct design torque during the torque check process.Philips has investigated the reported screw heads not torqued to specification (12nm) on the spectral ct system.Broken or loose screws cannot be expelled and will remain contained within the gantry.The presence of loose or broken screws allows movement between components, generating abnormal acoustic noise during system rotation.This issue is not indicative of a systemic manufacturing defect, as current production process controls for screw torque are confirmed to be within specification.Refer to recall (z) number for additional information related to this allegation.

• Brand Name: 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: 23879398
• Report Number: 3015777306-2025-000013
• Device Sequence Number: 21238302
• Product Code: JAK
• UDI-Device Identifier: 00884838101111
• UDI-Public: (01)00884838101111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: SPECTRAL CT
• Device Catalogue Number: 728333
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z1315 2026, Z1316 2026,
• Patient Sequence Number: 1
• Patient Sex: Unknown