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Recall Observatory FDA recall evidence

Derived label

Device software or design

RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
issue was found in Software
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
RAYSEARCH LABORATORIES AB

Field note

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