Recall Z-3248-2024 ยท OTE Digital Breast Tomosynthesis
Hologic Inc
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.
| Date | Sep 25, 2024 (initiated Aug 19, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| 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 t |
| Quantity | 425 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.