DICOM GRID INC recalls Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a

Recalled January 25, 2017 · FDA recall Z-1045-2017 · DICOM GRID

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. · FDA Class II

Units

209

Sold at

U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia.

Description

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.

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.

Manufacturer(s)

DICOM GRID INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →