Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for Recalled by DICOM GRID INC Due to A software error caused the window/level to become...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DICOM GRID INC directly.
Affected Products
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
Quantity: 209
Why Was This Recalled?
A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.
Where Was This Sold?
This product was distributed to 26 states: AZ, CA, CO, CT, FL, GA, HI, IL, KS, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NY, OH, PA, TX, UT, VA, WA, WI
About DICOM GRID INC
DICOM GRID INC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report