MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 2D; 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	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, our customer reported an incident with our selenia dimensions mammography system in which uncommanded motion was reported.On (b)(6) 2025, our field service engineer confirmed that c-arm moved in an irregular downwards direction slightly up/down direction without any command.The field engineer found a dry vta spindle and successfully cleaned it and re-greased according to manufacturer´s specifications.The device met the manufacturer´s specifications.The incident occurred before the patient exam/procedure.No injury was reported to the user/staff.No other information available.
Additional Manufacturer Narrative
An investigation was conducted: on january 2, 2025, a customer reported that there was a vta error code on a selenia dimensions (serial number (b)(6)).There was no alleged patient/user impact or injury.The issue persisted after power cycling the system.On the same day, january 2, 2025, the field service engineer (fse) noted that the vertical transport assembly (vta) lead screw (also known as the spindle) was dry.After the fse regreased the lead screw, the error did not return when tested.No parts were replaced, so the investigation will be limited to a device history review.From the service records, the most recent preventive maintenance (pm) prior to the incident was completed on december 18th, 2023.The following pm was performed on (b)(6) 2025, after the incident.The effective pm instruction for selenia dimensions/3dimensions at the time of the incident details how to remove and reapply fresh grease to the lead screw.The service checklist from december 2023 pm documented was reviewed and the step for cleaning, lubricating, and inspecting the vta was marked as completed.As for operating conditions, ¿selenia dimensions system user guide¿ states that the relative humidity range for operation is 20-80%.It is possible that the relative humidity is low at the customer site, which could lead to the grease drying between the pm in (b)(6) 2023 and the incident.It is also possible that an insufficient amount of grease was applied or was not evenly applied across the lead screw.The root cause is unknown as the relative humidity of the customer site was not provided, and it is not possible to determine if sufficient grease was applied evenly.Conclusion: in summary, the root cause is unknown; the probable causes are insufficient grease applied evenly across the lead screw during the preventive maintenance (pm) about 13 months prior to the incident or possible low relative humidity at the customer site.Either could cause the lead screw grease to dry before the next pm.There was no alleged injury.This behavior will continue to be monitored and trended.Device history record (dhr) review: system serial number: (b)(6).System sku: sda-sys-3000-2d.Date of manufacture: 9/13/2016.Udi: (b)(4).Dhr review summary: there were no discrepancies related to the lead screw or vta movement.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM, 2D
• Common Device Name: FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: daniel guevara ; coyol free park zone b24; alajuela 20102
• MDR Report Key: 21218189
• Report Number: 1220984-2025-00007
• Device Sequence Number: 3442038
• Product Code: MUE
• UDI-Device Identifier: 15420045510616
• UDI-Public: (01)15420045510616(11)160913
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2016
• 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