MAUDE Adverse Event Report: Philips Medical Systems DMC GmbH Raidography 7000 M; SYSTEM, X-RAY, MOBILE

Model Number	Radiography 7000 M
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system stopped driving after completion of a patient examination.After rebooting the system, it would only drive in reverse at full speed.The device was out of clinical use, and there was no patient or user harmed.
Additional Manufacturer Narrative
Reference id- (b)(4).The radiography 7000 m is a motorized mobile x-ray system designed for diagnostic imaging of both adult and pediatric patients who cannot be transferred to a stationary x-ray system.It supports imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, and abdomen, in multiple positions such as sitting, standing, and lying (prone or supine).Philips received a complaint regarding a radiography 7000m system, where the customer reported that the system stopped driving after completion of a patient examination.After rebooting the system, it would only drive in reverse at full speed.The device was out of clinical use, and there was no patient or user harm.The remote service engineer (rse) discussed the issue with the customer.The customer reported that the system stopped driving after completion of a patient examination and that, following a reboot, it would only drive in reverse at high speed.The issue could not be resolved remotely and required onsite support.The field service engineer (fse) visited the site, reviewed the log files, and identified the driving issue.The fse then removed the covers, verified the led (light emitting diode) states, and reseated the cable between j5 on the admc (axis drive motor controller) and j1 on the handle capacitive switch pcb (printed circuit board).After this, the system resumed normal driving.Investigation is in-progress.

• Brand Name: Raidography 7000 M
• Common Device Name: SYSTEM, X-RAY, MOBILE
• 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: 50880337
• Report Number: 3003768251-2026-100036
• Device Sequence Number: 10705224
• Product Code: IZL
• UDI-Device Identifier: 00884838115521
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233678
• 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): 09/24/2026

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 7000 M
• Device Catalogue Number: 712010
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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