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	08/31/2026
Type of Reportable Event	Malfunction

• 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: 50929310
• Report Number: 3003768251-2026-100039
• Device Sequence Number: 21516330
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• 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