Z-0840-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- January 3, 2018
- Termination Date
- July 2, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: 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.
Reason for Recall
Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
Distribution Pattern
Worldwide Distribution - US Nationwide
Code Information
Brilliance Big Bore Oncology CT, Model # 728243 Serial #s: 76025 76022 76024 76023 76016 76021 76008 76010 76002 76020 76011