Spectral CT on Rails: Software Version 5.1.0.X, model 728334.

Reason: A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.

Code information: UDI-DI: 00884838103627, serial number: 1005.

Distribution pattern: Worldwide - US Nationwide distribution in the states of AR, AZ, GA, HI, IN, KY, MA, MD, MN, NY, OH, PA, TX & WV; the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, Germany, Israel, Italy, Japan, Macao, Malaysia, Netherlands, Norway, Palestine, Panama, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand & United Kingdom.