MAUDE Adverse Event Report: IMRIS IMAGING, INC. ORT200 TABLE; OPERATING ROOM TABLE

Model Number	ORT200
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The imris field service engineer isolated the cause to an actuator component within the table's rotational locking mechanism.The field engineer rotated the table and re-engaged the locking mechanism, which successfully locked the table position.End user was informed of the finding and the actuator component is in process of being replaced.An internal corrective action has been initiated by the manufacturer to further address this issue.
Event or Problem Description
During the one(1) year preventative maintenance (pm), the manufacturer's field service engineer reported the rotational lock on the ort200 operating room table was struggling to obtain the lock status.There was no patient involvement.

• Brand Name: ORT200 TABLE
• Common Device Name: OPERATING ROOM TABLE
• Manufacturer (Section D): IMRIS IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer (Section G): IMRIS IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: stacy kramer ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036338
• MDR Report Key: 23383734
• Report Number: 3010326005-2025-00003
• Device Sequence Number: 18315260
• Product Code: KXJ
• UDI-Device Identifier: 00857534006349
• UDI-Public: (01)00857534006349(11)20151125
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/24/2025

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
• Device Model Number: ORT200
• Device Catalogue Number: 114148-000
• 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: 10/02/2025
• Initial Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2015
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown