Merge RadSuite software recalled due to incorrect pixel value data
Merge Healthcare is recalling RadSuite software version V8.30.7.8 because incorrect pixel values may lead to patient injury or delayed diagnosis.
What this means for you
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 medical device software defect that may result in patient injury or delayed diagnosis, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merge Healthcare, Inc. is recalling Merge RadSuite software, version V8.30.7.8. The recall is due to a defect where the values provided from the Pixel Value tool do not appear to be correct.
The potentially affected software was distributed to medical facilities in Alabama, Indiana, Michigan, Pennsylvania, and Wisconsin. A total of 8 sites have the potentially affected version.
The incorrect data may result in potential patient injury or delay in diagnosis or treatment. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 8
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 V8.30.7.8
Distribution
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