The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 The display defect could result in clinicians reviewing outdated diagnostic information, potentially leading to clinical errors in patient care.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 The failure to display the latest report by default could result in clinicians reviewing outdated diagnostic information instead of the most recent findings, potentially impacting clinical decision-making.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…
Manufacturer
GE Healthcare
Category
Medical Device — Imaging Software
Hazard
Affected units
1,500

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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