Z-1492-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- February 23, 2017
- Termination Date
- February 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Reason for Recall
When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Distribution Pattern
Worldwide Distribution - US to AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX & WI; Internationally to the following countries: Australia, Austria, Canada, China, Czech Republic, Germany, India, Israel, Jordan, Korea, Mexico, New Cldonia, Romania, Russian Federation, Turkey, & United Kingdom.
Code Information
System Serial Number - 76002, 76008, 76010, 76011, 76016, 76020, 76021, 76022, 76023, 76024, 76025