Z-1054-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 14, 2024
- Initiation Date
- December 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 1
Product Description
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Reason for Recall
A software issue that can incorrectly label all captured images that may lead to misdiagnosis and subsequent incorrect treatment.
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.
Code Information
UDI-DI: 00884838103627, serial number: 1005.