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	10/23/2025
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 (b)(6) 2025 a customer at (b)(6) reported a knocking noise and the gantry was wobbling on a spectral ct 7500 system (sn (b)(6), product number 728333).The system was in use at the time of the initial report by the user.There was no harm to the user, patient or bystander as a result of this issue.The fse was onsite to investigate and reported the following issue: while inspecting the gantry plate, the engineer found broken screw heads in the bottom of the gantry.The screw heads were broken off from the screws used to attach the bearing ring to the back plate (bearing ring and back plate are part of assembly 459801335243 rotor assembly-fabrication).While inspecting the remaining accessible bolts, the fse found additional broken or partially broken screws and the remaining screws were not torqued to the required 12nm.The fse removed the screws and the used loctite from the screw hole.There was a request made to keep all broken or damaged parts for further investigation, and the system was removed from service until a replacement could be supplied to the customer.During the engineering investigation, they found 11 broken screws, 2 almost broken screws, and 19 that were not torqued correctly.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 and not likely to result in medically reversible or transient adverse health consequences.Philips has started an investigation into this event.We will file a follow-up/final mir at the completion of the investigation.
Additional Manufacturer Narrative
Philips previously reported an allegation of a knocking noise, and the gantry was wobbling on a spectral ct 7500 device.There was no report of patient harm or injury.Philips has investigated the reported abnormal noise and wobbling during gantry rotation on the spectral ct system.A philips field service engineer (fse) inspected the system onsite.According to the investigation, the fse identified two broken screws at the bottom of the gantry.While searching for the source, they discovered additional screws loose and partially broken associated with the bearing ring fixation to the rear plate.Further inspection determined that the broken screws cannot be expelled and they remain contained within the gantry.Of the 23 screws inspected, 10 were found to be broken and 13 were under torqued (<5nm), compared to the specified 12nm specification.The failed screws were analyzed by a third party, which confirmed fatigue fracture mode.The root cause was determined to be insufficient torque applied to the screws during assembly, resulting in inadequate clamping force between the bearing ring and rear plate.This condition led to relative movement, increased cyclic stress, and subsequent fatigue failure of the screws.The loosened and broken screws allowed 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 previous section for recall (z) numbers associated with 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: 23879396
• Report Number: 3015777306-2025-000012
• Device Sequence Number: 9622475
• Product Code: JAK
• UDI-Device Identifier: 00884838101111
• UDI-Public: (01)00884838101111
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care 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: Health Professional
• Device Model Number: SPECTRAL CT
• Device Catalogue Number: 728333
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: 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