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Recall Observatory FDA recall evidence

Derived label

Device software or design

Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may
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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