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Recall Observatory FDA recall evidence

Derived label

Device software or design

Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Stryker Corporation

Field note

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