The Recall Desk
HighFDA (Devices)·Z-0039-2025·Announced 2024-10-16

GE Healthcare Centricity Universal Viewer may fail to display latest diagnostic report

GE Healthcare Centricity Universal Viewer Zero Footprint Client version 6.0 SP11.x may fail to show the latest diagnostic report by default when a study contains multiple DICOM structured reports in different series.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device classified as risk-of-harm product where injury has not yet been reported. The display defect could result in clinicians reviewing outdated diagnostic information, potentially leading to clinical errors in patient care.

Plain-English summary

GE Healthcare is recalling Centricity Universal Viewer Zero Footprint Client version 6.0 SP11.x due to a display defect. In this software version, the latest diagnostic report may not be displayed by default to users when a study contains multiple DICOM structured reports (preliminary, final, and/or addendum) stored in different series.

This issue affects healthcare professionals using the affected software to review medical imaging studies. The failure to display the latest report by default could result in clinicians reviewing outdated diagnostic information instead of the most recent findings, potentially impacting clinical decision-making.

Approximately 1,500 units have been distributed worldwide. GE Healthcare is notifying affected customers of this issue.

The recalled product

Product
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿
Manufacturer
GE Healthcare
Category
Medical Device — Imaging Software
Hazard
  • display-error
  • missing-report

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a)¿¿¿¿¿2089507-120
  • UDI/DI 840682102988
  • b)¿¿¿¿ 2089507-129
  • 332068-Centricity Universal Viewer Zero Footprint / ZFP-20274641
  • RU9594-Centricity Universal Viewer Zero Footprint / ZFP-19628991
  • c)¿¿¿¿¿ 2089507-131
  • 2722622-Centricity Universal Viewer Zero Footprint / ZFP-19663680
  • RU3232-Centricity Universal Viewer Zero Footprint / ZFP-20080525
  • RU1857-Centricity Universal Viewer Zero Footprint / ZFP-20022263
  • d)¿¿¿¿ 2089507-135
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555362
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555363
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555364
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555365
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-00555367
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21286328
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21286332
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21767150
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21770700
  • 3480-29-Centricity Universal Viewer Zero Footprint / ZFP-21770743

Distribution

Distribution scope not specified by the agency.

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