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U.S. Department of Health and Human Services

Class 2 Device Recall Selenia Dimensions/ 3Dimensions

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 Class 2 Device Recall Selenia Dimensions/ 3Dimensionssee related information
Date Initiated by FirmAugust 19, 2024
Date PostedSeptember 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3248-2024
Recall Event ID 95286
PMA NumberP080003 
Product Classification Digital breast tomosynthesis - Product Code OTE
ProductSelenia 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)
Code Information UDI-DI: 15420045505636, 15420045511897 Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View¿ software
Recalling Firm/
Manufacturer		 Hologic Inc
600 Technology Dr
Newark DE 19702-2463
For Additional Information ContactBreast Health Customer Support
+1-877-3714372
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Software design
ActionHologic 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
Quantity in Commerce425 units
DistributionWorldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = OTE
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