Merge Unity PACS Software Recalled for Missing Demographic Data
Merge Healthcare is recalling Unity PACS software version 11.0 because reports faxed to referring physicians were missing demographic header information.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that no illnesses or injuries have been reported, and the hazard is a documentation error rather than a direct physical safety risk.
Plain-English summary
Merge Healthcare, Inc. is recalling DR Systems Unity PACS software, now known as Merge Unity PACS, version 11.0. The recall was initiated because reports were missing demographic header information when they were faxed to referring physicians.
The affected software was distributed to medical facilities in California, Montana, Pennsylvania, and Texas. There was no foreign, military, or government distribution. Nine sites potentially have the affected version of the software.
This is a Class II recall. The FDA has not reported any illnesses or injuries associated with this defect. Users of the affected software should contact Merge Healthcare for further instructions on how to resolve the issue.
The recalled product
- Product
- DR Systems Unity PACS software, now known as Merge Unity PACS
- 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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