US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
Description du dispositif
Ingenuity Core 128-Computed Tomography X-ray system || Product Usage: || The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes..
Those issues are software related. To determine whether your system is affected, you must have one of the following systems and an affected software version:
Issue 1: Image Position Accuracy issue due to Image Rotation Calibration Software Error on : Brilliance 16-Slice (Air), Brilliance CT Big Bore, Ingenuity Flex
Issue 2: Tracker Image Artifact issue due to Reconstruction Software Error on : Brilliance 16-Slice (Air), Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128, Brilliance CT Big Bore, Ingenuity Flex
Issue 3: Image Artifact issue due to X-ray Measurement Firmware Error on : Brilliance 64 CT, Ingenuity Core, Ingenuity Core 128
All Issues: affected software versions: 3.6.1, 3.6.2, 3.6.4, 3.6.5
The following CT systems with a specific patient support / couch manufacturing lot are affected:
- Brilliance CT 16 Air
- Brilliance CT 64
- Brilliance CT Big Bore Oncology & Radiology
- iCT
- iCT SP
- Ingenuity CT
- Ingenuity Core
- Ingenuity Core 128
- Ingenuity Flex