Merge Healthcare Recalls CADstream Software Due to Incorrect Patient Follow-up
Merge Healthcare is recalling CADstream software versions prior to 5.2.6 because changes to study protocols may result in incorrect patient follow-up.
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 medical device software defect that can lead to incorrect patient follow-up, representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Merge Healthcare, Inc. is recalling CADstream software versions prior to 5.2.6. CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies, as well as to provide workflow efficiency and interventional planning tools.
The recall is due to a software issue where study preferences may not update correctly when changes are made to the study protocol. This malfunction can result in incorrect patient follow-up.
The affected software is distributed nationwide in the United States, with 844 sites potentially having the affected versions. Users of CADstream software should contact Merge Healthcare for further instructions on updating the software to version 5.2.6 or later.
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
- 844
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 prior to 5.2.6
Distribution
Distributed nationwide across the United States.
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