MAUDE Adverse Event Report: STERIS CORPORATION; CMAX X-RAY SURGICAL TABLE

Model Number	CMAX X-RAY IMAGING TABLE
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found that the override system and the main board required replacement.To resolve the issue, the technician replaced the override system and main board, tested the unit, confirmed it to be operating according to specification, and returned to service.A 3-year complaint review has considered the reported event to be isolated.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, their cmax x-ray surgical table did not respond to hand controls commands.The procedure was completed successfully on the same table.No report of injury or procedure delay.

• Brand Name: NA
• Common Device Name: CMAX X-RAY SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25050264
• Report Number: 1043572-2026-00043
• Device Sequence Number: 10457583
• Product Code: GDC
• UDI-Device Identifier: 00724995216825
• UDI-Public: (01)00724995216825(11)231121
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CMAX X-RAY IMAGING TABLE
• Device Catalogue Number: ST0161000
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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