MAUDE Adverse Event Report: Hologic, Inc 3Dimensions; Mammography System

Model Number	3DM-SYS-STD
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Emits Odor (1425); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a dimensions system displayed an error related to high voltage arc detected, during a quality control testing.The system remained nonoperational following a reboot.No patient or user impact was reported.During service evaluation, the field service engineer identified arcing of the high voltage cable inside the generator and found the cable to be burnt.The high-voltage cable was replaced.An unpleasant odor for the generator during operation was also reported.The x-ray tube and generator were subsequently replaced; however, intermittent errors persisted.Following the replacement of the resistor pack, the errors cleared.Required generator and automatic exposure control calibrations were completed, and the system was verified to be operating to manufacturer specifications.

• 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 drive; newark DE 19702
• Manufacturer Contact: heather bager ; 445 simarano drive; marlborough, MA 01752
• MDR Report Key: 50949312
• Report Number: 3005496266-2026-00292
• Device Sequence Number: 9534722
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: 15420045510524
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 09/30/2026

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: Other
• Device Model Number: 3DM-SYS-STD
• Device Catalogue Number: 3DM-SYS-STD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown