MAUDE Adverse Event Report: HOLOGIC, INC 3DIMENSIONS; MAMMOGRAPHY SYSTEM

Model Number	3DM-SYS-STD
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that on (b)(6) 2026, during use of a 3dimensions, the c-arm moved unexpectedly during a patient exam while positioned at 90 degrees for a left true lateral tomosynthesis exposure.The user site reported that the c-arm shifted from approximately 90 degrees to 92 degrees while the patient was in compression and that the movement was visible.It was reported by the user site that after the shift occurred, the system shut down.No patient impact or injuries were reported, and exams were completed in another room.A hologic field service engineer (fse) investigated the device and found that the c-arm was moving slightly during tomosynthesis at 90 degrees.The fse inspected the vertical travel assembly (vta) and reported that no loose bolts or vta movement were found.The fse reported that the c-arm brakes were sticking during the tomosynthesis sweep at 90 degrees, causing the system to shut down.Both c-arm brakes were replaced by the fse, and all required checks and calibrations were performed.Following repair, the fse reported that no errors occurred during testing and the system was verified to be operating according to manufacturer specifications.No further information is currently available.

• Brand Name: 3DIMENSIONS
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 600 technology dr; newark DE 19702
• Manufacturer (Section G): HOLOGIC, INC; 600 technology dr; newark DE 19702
• Manufacturer Contact: dara smithers ; 600 technology dr; newark, DE 19702
• MDR Report Key: 25494133
• Report Number: 3005496266-2026-00149
• Device Sequence Number: 10013344
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: (01)15420045510524(11)200219
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/27/2026

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: 3DM-SYS-STD
• Device Catalogue Number: 3DM-SYS-STD
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2020
• 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