Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RadSuite software. The firm name on the label is Merge Healthcare Recalled by Merge Healthcare, Inc. Due to Interventional Radiology (IR) images are stored as JPEG2k...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Merge Healthcare, Inc. directly.
Affected Products
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.
Quantity: 96 sites potentially have the affected versions for both products
Why Was This Recalled?
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
Where Was This Sold?
This product was distributed to 2 states: CO, OK
About Merge Healthcare, Inc.
Merge Healthcare, Inc. has 93 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report