FDA-Device2026-03-11Class IIPROCESSING DEFECT

GE Healthcare Centricity Universal Viewer Zero Footprint Client recalled for patient data mismatch

OTHERNationwide distributionMedical devices

What this means

GE Healthcare has identified a software issue in certain versions of its Centricity Universal Viewer Zero Footprint Client where patient information displayed in the viewer may not match the medical images being shown. This could occur in specific workflows on systems with Patient Timeline installed. The issue affects approximately 250 units.

If your healthcare facility uses GE Healthcare Centricity Universal Viewer Zero Footprint Client (versions ZFP v6.0: SP11.6, SP11.6.0.1, or SP11.6.1), contact GE Healthcare immediately
Verify patient information matches displayed images during interpretation workflows
Follow GE Healthcare's guidance on software updates or patches to resolve the issue

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The agency's original wording

Hazard

Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide distribution - US Nationwide and the countries of Belarus, Brazil, Canada, China, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Lebanon, Malaysia, Netherlands, Philippines, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkiye, United Arab Emirates, United Kingdom, Vietnam.

Affected count

250 units

Manufactured in

500 W Monroe St, N/A, Chicago, IL, United States

Products

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1475-2026

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