Derived label

Device software or design

Brilliance 16, Model number 728246 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.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can
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