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Recall Observatory FDA recall evidence

Derived label

Device software or design

Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
cybersecurity vulnerability
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
GE Medical Systems, LLC

Field note

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