MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number	SDM-SYS-9000-2D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that prior to a selenia dimensions mammography system procedure on (b)(6) 2026 that the compression device was not moving smoothly, with ¿rough¿ motorised compression noted.The user site reported that looseness was found by an engineer during a previous visit to the site.No user or patient injuries were reported.A (hologic field service engineer (fse) was dispatched to investigate the device and observed that the gear motor assembly had rusted and was slipping, then replaced the gear motor assembly and compression thickness potentiometer, reset cdi defaults, and performed all compression calibrations.The fse confirmed motor compression was smooth and compression thickness accurate for normal and verified that the system is now operating according to manufacturer specifications.No further information is currently available.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS
• Common Device Name: FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 600 technology drive; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC.; 600 technology drive; newark DE 19702
• Manufacturer Contact: ugo chibueze ; 445 simarano dr; marlborough, MA 01752
• MDR Report Key: 24722786
• Report Number: 3005496266-2026-00067
• Device Sequence Number: 18695824
• Product Code: MUE
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010025
• 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): 08/03/2026

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-9000-2D
• Device Catalogue Number: SDM-SYS-9000-2D
• 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: 02/27/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2017
• 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