Merge Healthcare Recalls CADstream MRI Software Due to Grid Selection Error
Merge Healthcare is recalling CADstream software versions 4.1.3 and prior because an incorrect grid selection could lead to an incorrect biopsy or missed target during MRI analysis.
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 the hazard involves a risk of harm (incorrect biopsy or missed target) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Merge Healthcare, Inc. is recalling CADstream software, an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. The recall affects versions 4.1.3 and prior versions. The software is intended to provide workflow efficiency and interventional planning tools.
The recall is being issued because an incorrect biopsy or missed target could result if the incorrect grid is selected within the application. This defect poses a risk to patient safety during interventional planning.
Approximately 1,349 sites potentially have the affected versions of the software. The product was distributed nationwide in the United States. Users of the software should contact Merge Healthcare, Inc. for further instructions on how to address the issue.
The recalled product
- Product
- CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning…
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Affected units
- 1,349
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)
- All versions - Versions 4.1.3 and prior versions
Distribution
Distributed nationwide across the United States.
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