FDA-Device2017-01-25Class II
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
DICOM GRID INC
Hazard
A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.
Sold states
U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain, Israel, Singapore, Kosovo, Austria, Brazil, Malaysia, Australia.
Affected count
209
Manufactured in
4530 E Muirwood Dr, Ste. 113, Phoenix, AZ, United States
Products
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1045-2017Don't want to check this manually?
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