MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; 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	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on april 3rd, 2025, that a customer received an error code on a selenia dimensions mammography system.A field engineer was dispatched to examine the equipment and found the c-arm was moving down without command.The field engineer determined that the issue was due to a malfunctioning foot switch.The field engineer replaced the foot switch and tested the system to ensure it is functioning in accordance with manufacturer specifications.No patient/user injury was reported.
Additional Manufacturer Narrative
On (b)(6) 2025, a customer observed that the c-arm moved downwards without user input on a selenia dimensions (serial number (b)(6).This occurred prior to a patient exam/ procedure.There was no alleged health impact or consequence to the patient/user.The field service engineer (fse) swapped the footswitches (left and right) and no longer observed the behavior.The part was not replaced.Because of this, there was no part returned, and no initial evaluation performed.Because the part was not available, the investigation is limited to a complaint review.There were no prior footswitch related issues or uncommanded motion issues after the fse performed the troubleshooting.Possible causes for footswitch issues include wear and tear due to part use or debris accumulation due to its location on the floor.The footswitch was not returned; therefore, further investigation could not be performed.Due to the limited information provided and lack of part return, the root cause of the failure could not be determined.Conclusion: the probable cause is a stuck footswitch; the root cause is unknown due to the unreturned part.The severity for this incident is very low, and the calculated post risk control risk index is considered acceptable (level 1) per the gemini risk management plan (pln-00140 rev 4) and risk management procedure (eng-0042 rev 22).Because of this, and because there was no severe injury, no capa is required.This will continue to be trended and monitored.Complaint confirmed: no device history record (dhr) review: udi: (b)(4), sku: (b)(6), serial number: (b)(6), date of manufacture: 9/12/2022, installation date: (b)(6) 2022, incident date: (b)(6) 2025, closest pm to complaint date: (b)(6) 2025, date of part manufacture: unknown.Dhr review summary: there were no noted discrepancies.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• 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: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 21865652
• Report Number: 1220984-2025-00052
• Device Sequence Number: 14633029
• Product Code: MUE
• UDI-Device Identifier: 15420045510616
• UDI-Public: (01)15420045510616(11)220912
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 07/08/2025

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: 04/03/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2022
• 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