MAUDE Adverse Event Report: STEPHANIX STEPHANIX; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	D2RS TYPE 9090
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a movement ordered from the console by a radiology operator, the table did not stop.No patient, no injury.The user did not use the emergency stop buttons.After analysis of the logs by our support team, we found that when the tilting control was released, a bug occurred in the inverters and movement continued without reaching the limit switch.We have implemented a hardware safety which monitors if an abnormal situation like this occurs and cuts the power so that the movement stops immediately.During this issue, the contactor failed to open properly and the equipment remained powered.Our technical team adjusted the limit switch and changed the contactor (manufactured by schneider electric), the component that cuts off the power when the problem occurs.

• Brand Name: STEPHANIX
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): STEPHANIX; 10 rue jean moulin; zi du bayon; la ricamarie, 42150 ; FR 42150
• Manufacturer (Section G): STEPHANIX; 10 rue jean moulin; zi du bayon; la ricamarie, 42150 ; FR 42150
• Manufacturer Contact: sandie perret ; 10 rue jean moulin; zi du bayon; la ricamarie, 42150 ; FR 42150
• MDR Report Key: 22506256
• Report Number: 3006972752-2025-00001
• Device Sequence Number: 8625098
• Product Code: OWB
• UDI-Device Identifier: 03664049001052
• UDI-Public: 03664049001052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: D2RS TYPE 9090
• 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: 06/24/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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