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Recall Observatory FDA recall evidence

Derived label

Device software or design

SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software bugs in VC20B SP0a or SP1 software versions may cause issues that could
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Siemens Medical Solutions USA, Inc

Field note

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