Derived label

Device software or design

The Brilliance iCT and iCT SP are 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 analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software upgrade. None of these nonconformances result in
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Philips Medical Systems (Cleveland) Inc