Z-1045-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2017
- Initiation Date
- December 16, 2016
- Termination Date
- April 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 209
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.