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Recall Observatory FDA recall evidence

Derived label

Device software or design

Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software issues may occur in Vista software version 3.6.1. Issue
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Siemens Healthcare Diagnostics, Inc.

Field note

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