Merge PACS Software Recalled for Potential Incorrect Patient Image Display
Merge Healthcare is recalling Merge PACS software version 7.0.1 because it may display incorrect patient images, potentially delaying diagnosis or treatment.
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 software) where injury or death has not yet been reported, but the potential for delayed diagnosis or treatment constitutes a significant health risk.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge PACS software, version 7.0.1. The recall is due to a potential issue where the software may display an incorrect patient image. This error could result in a delay in diagnosis or treatment for patients.
The potentially affected software was distributed to 29 medical facilities in Arizona, California, Colorado, Florida, Hawaii, Illinois, Massachusetts, Maryland, Michigan, Missouri, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Utah, and Wisconsin. There was no distribution to foreign, government, or military entities.
Healthcare facilities should contact Merge Healthcare for instructions on how to address the software issue. Patients who have had imaging studies performed at these facilities should consult their healthcare provider if they have concerns about the accuracy of their medical records.
The recalled product
- Product
- Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 29
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 7.0.1
Distribution
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