Derived label

Device software or design

Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the clinician for clinical diagnosis purposes.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: Software issue
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.