Derived label

Device software or design

Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software versions 1.0 and 1.0 SP! have a software defect
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Thermo Finnigan LLC