Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Merge PACS software. The firm name on the label is Merge Healthcare Recalled by Merge Healthcare, Inc. Due to When measuring a lesion on an unmagnified mammography...
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
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Quantity: 49 sites potentially have the affected versions
Why Was This Recalled?
When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.
Where Was This Sold?
Worldwide Distribution -- USA and Australia.
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