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FDAMay 22, 2019device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

ge healthcare

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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