MAUDE Adverse Event Report: Philips Medical Systems DMC GmbH Radiography 7300 C; System, X-Ray, Stationary

Model Number	Radiography 7300 C
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Pain (1994); Muscle/Tendon Damage (4532)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ceiling suspension (cs) was difficult to move in all directions, including longitudinal and transverse movement.The device was in clinical use and one radiographer reported experiencing a strained shoulder associated with use of the room.
Additional Manufacturer Narrative
Reference id: (b)(4).The radiography 7300 c is a high-end digital system featuring a height-adjustable patient support table and a ceiling suspension with a movable tube and control handle.It includes a philips x-ray generator and a pixium 4343rce flat panel rad detector, forming the radiography image chain.The system also offers a portable wireless detector option, the skyplate family, for flexible exposures.Philips received a complaint on radiography 7300 c indicating that the ceiling suspension (cs) was difficult to move in all directions, including longitudinal and transverse movement.The device was in clinical use and one radiographer reported experiencing a strained shoulder associated with use of the room.A good faith effort (gfe) was raised, and it was confirmed that the symptoms resolved with supportive non-prescription pain relief and intermittent avoidance of use/rest.Therefore, based on the information available, the event does not meet the criteria for a serious injury and is assessed as minor in nature.The field service engineer (fse) visited the site and collected movement force measurement data for review by technical support specialist (tss).Evaluation confirmed that adjustment of the counterbalance spring resulted in the expected decrease of force in one direction and increase in the opposite direction.No difference in vertical movement stiffness was observed between power-on and power-off conditions.Further discussions with management and tss indicated that an additional onsite visit is planned to perform more in-depth testing and evaluate potential adjustments.In addition, the applications team is scheduled to attend the site to review and optimize geometry positions, with the goal of enabling greater movement using the remote control.Investigation in-progress.

• Brand Name: Radiography 7300 C
• Common Device Name: System, X-Ray, Stationary
• Manufacturer (Section D): Philips Medical Systems DMC GmbH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer (Section G): Philips Medical Systems DMC GmbH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer Contact: dusty leppert ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 50472977
• Report Number: 3003768251-2026-100025
• Device Sequence Number: 10094084
• Product Code: KPR
• UDI-Device Identifier: 00884838116016
• UDI-Public: (01)00884838116016
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K233662
• 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
• Report Date (Section B): 08/27/2026

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: Radiography 7300 C
• Device Catalogue Number: 712037
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2026
• 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
• Patient Sex: Unknown