FDA-Device2019-06-19Class II

GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

GE Healthcare, LLC
Hazard

There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.

Sold states
Worldwide
Affected count
620 units
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1781-2019

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