FDADecember 16, 2016device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
dicom griddicom
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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