GE Centricity Universal Viewer Zero Footprint…

Date

July 13, 2022

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

Ongoing

Filed by

GE Healthcare, LLC

Product

GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation.

Reason

Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)

Distribution pattern

Worldwide distribution.

Quantity

1,934 units

Codes and lots

UDI 00840682102988, Versions 6.0 SP6 through SP11.4

Recall started

June 8, 2022

Device type

System, Image Processing, Radiological

Root cause (FDA)

Software design

What the company told customers

GE notified their consignees by issuing an URGENT MEDICAL DEVICE CORRECTION notice on 08 June 2022. The letter explains the two safety issues and provides the following actions be taken: Issue #1: "You can continue to use your device in accordance with the User Manual and the actions below: Do not utilize any measurements when the 'Lossy' overlay is displayed in the lower left of the viewport and, when you hover over the word 'Lossy', it displays the tooltip box with the phrase 'Image scaled down from its original resolution'." Issue #2: "You can continue to use your device in accordance with the User Manuals and the actions below: Do not perform any measurement on non-squared pixel images. Always confirm critical diagnostic measurements by other means (i.e using a fiducial marker of known size)." GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction. After the software has been corrected, be sure to destroy the installation media for affected software at your site. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recall number

Z-1333-2022

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

Source: FDA · Medical device enforcement report, recall number Z-1333-2022. The agency record governs; check it and the company before acting.