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

Model Number	3DM-SYS-STD
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The field engineer reported that while onsite for an unrelated repair, a burning odor was detected, and a dtc error code was present.The system was immediately powered down.Upon investigation, a burned-out chip was identified on the dtc board.The board was replaced, which resoled the error.The system was confirmed to be functioning properly following repair.No patient or user impact was reported.
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device at the time of this report.A follow-up report will be submitted in the event additional information is received.

• 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 ; marlborough, MA 01752
• MDR Report Key: 50792898
• Report Number: 3005496266-2026-00253
• Device Sequence Number: 16094864
• Product Code: OTE
• UDI-Device Identifier: 15420045510524
• UDI-Public: 15420045510524
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/16/2026
• 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