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Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis recallZ-3248-2024 · Hologic Inc · initiated Aug 19, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hologic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software design

What the company is doing

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

Recall details

Recall number
Z-3248-2024
Status
Open, Classified
Initiated by the company
Aug 19, 2024
Posted by the FDA
Sep 25, 2024
Recalling firm
Hologic Inc
Quantity
425 units
Product code
OTE
FDA submissions
P080003
Distribution
Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Israel, Korea, Republic of, Netherlands.

Product description

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)

Code information (models, lots, serial numbers)

UDI-DI: 15420045505636, 15420045511897 Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View¿ software

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

14 devices cleared under P080003 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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