Derived label
Device software or design
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.