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

Model Number	SDA-SYS-3000-2D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user site reported that on (b)(6) 2025, prior to a selenia dimensions mammography system procedure, that the device generated an error code during use.No patient or user injury was reported.A hologic field service engineer (fse) was dispatched to examine the device and check the error code.The fse found that upon reviewing the movement graph of the device, it was observed that the c-arm performed vertical movements without receiving any commands.The fse found that the issue was traced to a malfunction in the motor clutch, which was subsequently replaced.The fse tested the device and verified that the device is now operating according to manufacturer specifications.No further information is currently available.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• 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 drive; marlborough, MA 01752
• MDR Report Key: 23752609
• Report Number: 3005496266-2025-00108
• Device Sequence Number: 15848876
• Product Code: MUE
• UDI-Device Identifier: 15420045510616
• UDI-Public: (01)15420045510616(11)221219
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: SDA-SYS-3000-2D
• Device Catalogue Number: SDA-SYS-3000-2D
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2022
• 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