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Recall Observatory FDA recall evidence

Derived label

Device software or design

TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
Failure of the LifeSPARC controller when the software
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Cardiac Assist, Inc

Field note

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