FDA Recall Open, Classified

Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.1 SYSTEMS 3. ASY-17219 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.10.0 SYSTEMS 4. ASY-17220 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.1.0 SYSTEMS 5. ASY-17221 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.0 SYSTEMS 6. ASY-17222 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM SOFTWARE UPGRADE FOR 2.2.0 SYSTEMS 7. 3DM-LIC-SW-UP-V2.3 DIMENSIONS SOFTWARE 2.3 (3DIMENSIONS) 8. SDM-LIC-SW-UP-V1.12 DIMENSION SOFTWARE 1.12 (SELENIA DIMENSIONS)

Recall: Z-3248-2024 · Initiated August 19, 2024

Recall

Recall Number: Z-3248-2024
Event Number: 95286
Firm: Hologic Inc
FEI Number: 3005496266
Product Code: OTE
Status: Open, Classified
Root Cause: Software design
Initiated: August 19, 2024
Posted: September 25, 2024
Address: 600 Technology Dr, Newark, DE, 19702-2463

Description

Reason

Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis

Action

Hologic issued Urgent: Medical Device Correction Fa-00248 letter via third party IQVIA on 8/30/24. Letter states reason for recall, health risk and action to take: For Health Care Providers with systems that do not have C-View software Customers may continue to use Dimensions 1.12.0 and 3Dimensions 2.3.0. For Health Care Providers with systems that do have C-View software (regardless of usage) Immediate action should be the discontinuation of C-View software usage. We will contact you to schedule a field visit from your field service engineer. Until your service appointment, you can continue to use your Selenia Dimensions 1.12.0 or 3Dimensions 2.3.0 system in Combo imaging mode to acquire tomosynthesis and FFDM images. During your appointment, one of the two following options will be completed by your selection: Option 1: C-View software will be disabled, and you can continue to use Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software in Combo imaging mode. Option 2: To resume using C-View software, system software will be downgraded to Selenia Dimensions 1.11.1 or 3Dimensions 2.2.1. "PLEASE NOTE: Downgrading to Selenia Dimensions 1.11.1 or 3Dimensions 2.2.1 systemsoftware will delete all data saved on the mammography system. You are responsible forbacking up all raw data saved on the mammography system prior to your serviceappointment. "The downgrade procedure will take approximately 4-8 hours to complete. "Once the mammography system is running Selenia Dimensions 1.11.1 or 3Dimensions 2.2.1,you may be able to reprocess certain saved images for reevaluation with C-View software;however, not all prior images may be reprocessed if the raw data associated with the imageis no longer available, such as those images saved on a Picture Archiving andCommunication System (PACS). A software upgrade will be available to correct the C-View issue on 1.12.0/2.3.0. A service appointment will be scheduled for an upgrade upon availability. Letter Receipt Requested We are

Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands.

Quantity

425 units