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Recall Observatory FDA recall evidence

Derived label

Device software or design

Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
PTW NORTH AMERICA CORPORATION

Field note

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