Merge Healthcare Recalls RadSuite Software Due to Image Display Errors
Merge Healthcare is recalling RadSuite software versions 8.30.6 through 8.30.6.3 because interventional radiology images are not displaying correctly.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a software display error without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity issue.
Plain-English summary
Merge Healthcare, Inc. is recalling specific versions of RadSuite software, a tool used to distribute, display, and store diagnostic-quality medical images. The affected versions are V8.30.6, 8.30.6.1, 8.30.6.2, and 8.30.6.3.
The recall was initiated because Interventional Radiology (IR) images stored as JPEG2k Lossless in Merge Enterprise Archive are not displaying correctly in RadSuite. This issue affects the accurate visualization of diagnostic images.
Approximately 96 sites in Colorado and Oklahoma potentially have the affected versions. Users of this software should contact Merge Healthcare for further instructions on resolving the display issue.
The recalled product
- Product
- RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
- Manufacturer
- Merge Healthcare, Inc.
- Category
- Medical Device — Software
- Hazard
- Affected units
- 96
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 (4)
- Versions V8.30.6
- 8.30.6.1
- 8.30.6.2
- and 8.30.6.3
Distribution
Part of a larger recall action
This product is one of 2 recalled by Merge Healthcare, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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