Hologic Recalls Selenia Dimensions and 3Dimensions Breast Imaging Software
Hologic is recalling Selenia Dimensions and 3Dimensions software due to a defect that may cause blurry images and potential misdiagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where the hazard is misdiagnosis (false negative), but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Hologic Inc. is recalling Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software. The recall involves 425 units distributed worldwide, including the United States, Belgium, Canada, Israel, Korea, and the Netherlands.
The recall was initiated because the software, when used in combination with C-View software, may produce final synthesized 2D images that appear blurry. This quality issue could result in misdiagnosis, specifically with the possibility of a false negative diagnosis.
Healthcare providers and facilities using these specific software versions should contact Hologic Inc. for instructions on how to resolve the issue. Consumers should not use the affected software for diagnostic purposes until the issue is addressed.
The recalled product
- Product
- 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…
- Manufacturer
- Hologic Inc
- Affected units
- 425
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 15420045505636
Distribution
Distributed nationwide across the United States.
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