Device Recall Ambra PACS

Radiology Devices

2

No

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.

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.