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Recall Observatory FDA recall evidence

Derived label

Device software or design

Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
firmware version 6.1.2 can
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Invacare Corporation

Field note

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