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

Model Number	SW-IC-AWS
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hologic is submitting this report in an abundance of caution, the investigation is still on-going , and no conclusions have been determined yet.
Event or Problem Description
It was reported that during a selenia dimensions procedure the image checker cad failed to indicate a region of interest on a patient.On 26 june the images were reviewed and it was determined that there was a mass present in the fatty region behind the primary dense tissue on the right breast that was not determined.No additional information available at the moment.The case is being investigated.
Additional Manufacturer Narrative
An investigation was completed: on (b)(6) 2024, imagechecker computer aided detection (cad) did not indicate a region of interest on a patient.The image science evaluation team identified that the software should have marked a mass in the fatty region behind the primary dense tissue on the right breast.There was no alleged health consequence or impact on the patient.Due to this being a software behavior, no parts were returned, and no initial evaluation could be performed.This is a missed region of interest by imagechecker cad.Imagechecker cad has overall sensitivity for biopsy proven cancers for cview images over 88%.There was no allegation against this sensitivity claim.The probable cause is that the sensitivity is 88% for detecting biopsy proven cancers per imagechecker cad 10.0 understanding guide.¿sensitivity¿ refers only to the sensitivity of the cad algorithm to detect biopsy-proven malignancies, not to the sensitivity of the radiologist using the device.The listed warnings and precautions of the understanding guide highlight the following: the radiologist should base interpretation only on diagnostic-quality images and not depend on imagechecker cad marks for interpretation; imagechecker cad is a detection aid, not an interpretative aid.The radiologist should activate imagechecker marks only after the first reading; the imagechecker cad software does not identify all areas that are suspicious for cancer; the software does not mark all lesions and a user should not be dissuaded from working up a finding if the software fails to mark the site; conditions of the breast that diminish mammographic sensitivity, such as density of normal tissue, also diminish the sensitivity of the software.There was no response from the customer if the lesion was proven cancerous, so it is possible that imagechecker cad accurately left the lesion unmarked.Due to the lack of follow up from the customer and images, the root cause is unknown.Conclusion: the customer alleged that the imagechecker computer aided detection (cad) missed a region of interest.Imagechecker cad has overall sensitivity for biopsy proven cancers for cview images over 88%.There was no response from the customer if the lesion was proven cancerous, so it is possible that imagechecker cad accurately left the lesion unmarked.It is also possible that the lesion was missed by the software.Therefore, the root cause is unknown.The radiologist followed the instructions in the understanding guide by using the software as an aid and was not dissuaded when a region of interest was not marked.Because there was no alleged harm and the occurrence is very low, no capa is required.Device history record (dhr) review: udi: (b)(4).Sku: sw-ic-aws.System serial number: (b)(6).Date of manufacture: 6/26/2023.Installation date: (b)(6) 2023.Incident date: (b)(6) 2024.Date of part manufacture: n/a ¿ imagechecker is not a manufactured part.Complaint history review: there were no prior or subsequent complaints related to imagechecker or cad.Dhr review summary: there is no dhr for imagechecker because imagechecker is software.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D
• Common Device Name: 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 ; 562 parkway; coyol free park zone b24; san jose 20102
• MDR Report Key: 19833512
• Report Number: 1220984-2024-00078
• Device Sequence Number: 18180314
• Product Code: OTE
• UDI-Device Identifier: 15420045500037
• UDI-Public: (01)15420045500037(10)10.0
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 10/15/2025

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: SW-IC-AWS
• Device Catalogue Number: SW-IC-AWS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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