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Recall Observatory FDA recall evidence

Derived label

Device software or design

Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013

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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