medical Class II Updated 2017-01-25

DICOM GRID INC recalls Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R S

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Affected States: TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, HI

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