Derived label

Device software or design

TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: problem of the X-ray output control software
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Toshiba American Medical Systems Inc