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Recall Observatory FDA recall evidence

Derived label

Device software or design

AMSCO 400 and AMSCO C Small Steam Sterilizers

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software inadvertently prevents
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Steris Corporation

Field note

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