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Centricity Universal Viewer 6.0, a device that displays medical images and data from various imag...

FDA Recall #Z-0819-2020 — Class II — December 16, 2019

Recall #Z-0819-2020 Date: December 16, 2019 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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.

Recalling Firm

GE Healthcare, LLC — Waukesha, WI

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

205

Distribution

Distributed nationwide; Internationally distributed to Mexico and 24 additional countries.

Code Information

Model 2088026-9XX Versions 6.0 SP10 or higher

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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