Derived label

Device software or design

Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software version 10.0 may
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Philips Ultrasound, Inc.