Device software or design

Assignment summary

Mode key

device_software_design

Evidence excerpt

Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can

Rule explanation

Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.

Firm

Fujifilm Medical Systems U.S.A., Inc.