Derived label

Device software or design

Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software problem
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: Carestream Health Inc.