Merge Unity PACS Software Recalled for Incorrect Mammogram Image Association
Merge Healthcare is recalling Unity PACS software version 11.0 because it may fail to associate the correct mammogram image when two images exist for the same view.
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 is classified as FDA Class II, which typically corresponds to a 'High' severity score (3) in the absence of reported hospitalizations or injuries, as the defect poses a risk of diagnostic error.
Plain-English summary
Merge Healthcare, Inc. is recalling DR Systems Unity PACS software, now known as Merge Unity PACS software, version 11.0. The recall is due to a defect where the software fails to associate the correct mammogram (MG) image if there are two images for the same view.
The software was distributed to medical facilities located in Montana, California, Pennsylvania, and Texas. Approximately nine sites potentially have the affected software installed.
This is a Class II recall, meaning there is a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. Users should contact Merge Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- DR Systems Unity PACS software, now known as Merge Unity PACS software.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 9
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)
- Version 11.0
Distribution
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