FDAClass IIJanuary 29, 2020

Centricity Universal Viewer 6.0 recall

Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information…

Why was Centricity Universal Viewer 6.0 recalled?

Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model 2088026-9XX Versions 6.0 SP10 or higher

Product
Centricity Universal Viewer 6.0, a device that displays medical images and data from various imaging sources, and from other healthcare information…
Recalling firm
GE Healthcare, LLC
Quantity
205
Distribution
Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.
Recall date
January 29, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls