Z-1333-2022Class II

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

Name: Z-1333-2022 GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and...
Creator: GE Healthcare, LLC
Published: 2022-06-08
License: https://open.fda.gov/license/

GE Healthcare / initiated 2022-06-08 / Open, Classified / root cause: software

FDA source

GE Healthcare, LLC began a recall of GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display Medical images and data within a computer network or on a workstation on 2022-06-08. FDA classified it as Class II and gives the reason as "Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1333-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-08
Posted: 2022-07-05
Recalling firm: GE Healthcare
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 1,934 units
Distribution: Worldwide distribution.
Product codes and lots: UDI 00840682102988, Versions 6.0 SP6 through SP11.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1333-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1333-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-05

Product code LLZ

K131977Class IICentricity Universal Viewer Zero Footprint ClientGE Healthcare / cleared 2013-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)