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Recall Observatory FDA recall evidence

Derived label

Device software or design

AMSCO 3000 Series Washer/Disinfector Model # 3052

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software in the systems may not process the cycle originally intended. This could result in
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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