Derived label

Device software or design

Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing hardware. Centricity Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Centricity Cardio Imaging is intended to assist trained professionals in the viewing, analysis and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians and assistants. Centricity Cardio Imaging is not intended for use in the patient vicinity.

reason.device_software_design

v1.0.0

Assignment summary

Mode key: device_software_design
Evidence excerpt: software of the Centricity Cardio Imaging product, version 5.0 SP1. Multiple studies may
Rule explanation: Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm: GE Healthcare It