Centricity Universal Viewer 6.0…

Date

Jan. 29, 2020

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

GE Healthcare, LLC

Product

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

Reason

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.

Distribution pattern

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

Quantity

205

Codes and lots

Model 2088026-9XX Versions 6.0 SP10 or higher

Recall started

Dec. 16, 2019

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

The firm initiated their correction on 12/16/2019 by letter. The letter explained the issue and directed the consignee to follow instructions in the letter until an update to the Centricity Universal Viewer can be made by the firm to correct the issue.

Recall number

Z-0819-2020

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0819-2020. The agency record governs; check it and the company before acting.