MAUDE Adverse Event Report: SHIMADZU COPORATION FDR GO; System, x-ray, mobile

Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported from usa that the cable was loosened and caused a small spark, but there was no melted part in the plug.Since the plug is see-through, revealing its internal components, it is easy for the user to notice when sparks are generated, so it is not considered that sparks are generated continuously.In addition, the material of the plug is flame retardant and has sufficient voltage resistance, so we do not think that it will heat up as users fear.
Event or Problem Description
We received the following report from fujifilm.On april 16th, 2025, fujifilm healthcare americas corporation was informed of an event involving fdr go plus e.The issue was that the plug may not be grounded, sparking inside of clear housing and causing the plug to heat up.The injury to the user or any patient involvement has not been confirmed at this time.This report is being submitted in an abundance of caution.

• Brand Name: FDR GO
• Common Device Name: System, x-ray, mobile
• Manufacturer (Section D): SHIMADZU COPORATION; 1, nishinokyo kuwabara-cho,; nakagyo-ku; kyoto, 60485 11; JA 6048511
• Manufacturer (Section G): SHIMADZU COPORATION; 1, nishinokyo kuwabara-cho,; nakagyo-ku; kyoto, 60485 11; JA 6048511
• Manufacturer Contact: takeshi yamamoto ; 1, nishinokyo kuwabara-cho,; nakagyo-ku; kyoto, 60485-11 ; JA 6048511
• MDR Report Key: 22368624
• Report Number: 8030233-2025-00001
• Device Sequence Number: 15441998
• Product Code: IZL
• UDI-Device Identifier: 04540217059379
• UDI-Public: (01)04540217059379(11)191017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 07/01/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown