Derived label

Device software or design

ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software (VA35E or VB10C depending on the hardware configuration). Hardware fixes will
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Siemens Medical Solutions USA, Inc.