FDAOctober 28, 2022device

Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imaging sources.

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

The hazard

There is the potential that after installation of the IAS tool, some studies can remain hidden without user notification. Access to those hidden studies requires GE Healthcare assistance, which can result in a delay in reading the study.

What to do

FDA enforcement status: Ongoing

Brands named

ge medical systems

UPCs

00059319600791020990494851350128227950958501826272601860017246758111100110911124774000002084828960054557485021

Recall history

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

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