MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

Model Number	SDM-SYS-9000-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that prior to a selenia dimensions mammography systems, 3d procedure on (b)(6) 2026, an error appeared when rotating the c-arm and it continued to rotate all the way around until it was upside down.The user site reported that the issue was resolved at the site by restarting the gantry, after which the system functioned normally.No user or patient injuries were reported.Hologic technical support advised the user to press the button firmly several times and to wiggle it to help dislodge any dust or debris that might have caused it to stick.The customer reported that no further events occurred after the buttons were adjusted.No further information is currently available.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 600 technology drive; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC; 600 technology dr; newark DE 19702
• Manufacturer Contact: dara smithers ; 445 simarano dr; newark, DE 19702
• MDR Report Key: 24761011
• Report Number: 3005496266-2026-00070
• Device Sequence Number: 9153453
• Product Code: OTE
• UDI-Device Identifier: 15420045510784
• UDI-Public: (01)15420045510784(11)180308
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P080003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2026

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: SDM-SYS-9000-3D
• Device Catalogue Number: SDM-SYS-9000-3D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2018
• 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