GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within

FDA device recall Z-1333-2022 · posted 2022-07-05 · Open, Classified

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

LLZ

Quantity affected

1,934 units

Distribution

Worldwide distribution.

Date initiated

2022-06-08

Date posted

2022-07-05

Location

Waukesha, WI

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