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

Model Number	3DM-SYS-INTL2D-MOB
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number assigned by national competent authority: (b)(4).On (b)(6) 2026, our distributor reported an issue with a 3dimensions mammography system.Specifically, during a patient examination, the right footswitch used to lower the c-arm became stuck, causing the c-arm to continue moving downward without command.No error messages were generated.The motion could be stopped manually by the operator.The field service engineer confirmed that the uncommanded vertical movement was caused by the defective footswitch.No patient or user injuries were reported.Our hologic technical service team reviewed the incident and confirmed that the right footswitch used to control the vertical c-arm movement was defective.The distributor¿s field service engineer replaced the footswitch assembly.After this intervention, the system started to operate normally.Our hologic technical service team has advised the distributor to continue monitoring the system and to report any recurrence of the issue.Confirmation will be provided in the final vigilance report.Imdrf codes: a0512, e2403, f26.

• 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: 25250717
• Report Number: 3005496266-2026-00113
• Device Sequence Number: 10623063
• Product Code: OTE
• UDI-Device Identifier: 15420045510593
• UDI-Public: (01)15420045510593(11)190404
• 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: 3DM-SYS-INTL2D-MOB
• Device Catalogue Number: 3DM-SYS-INTL2D-MOB
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2019
• 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