Derived label
Device software or design
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- incorrect manufacturing date/timestamp within the software
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.