Merge Healthcare Recalls Unity PACS Software Due to Image Error
Merge Healthcare is recalling Unity PACS software versions 11.0 and 11.0.1 because the software fails to add the correct tomo image.
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 and involves a medical device software defect that could impact diagnostic imaging accuracy, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Merge Healthcare, Inc. is recalling DR Systems Unity PACS software, now known as Merge Unity PACS, versions 11.0 and 11.0.1. The recall is due to a defect where the software is not adding the correct tomo image. Merge Unity PACS is a medical image and information management system used for viewing, processing, and printing medical images from various diagnostic imaging systems.
The affected software is distributed nationwide in the United States, specifically in the states of Alabama, California, Colorado, Florida, Illinois, Maryland, Minnesota, Montana, Nevada, New York, Oregon, Pennsylvania, South Carolina, Tennessee, and Texas. Approximately 28 sites potentially have the affected software installed.
Healthcare facilities using this software should contact Merge Healthcare for further instructions on how to resolve the issue. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a…
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 28
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)
- Versions 11.0 and 11.0.1
Distribution
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