GE Healthcare Recall: Centricity Universal Viewer Patient Image Mismatch
Summary
The FDA has issued a Class II recall for GE Healthcare's Centricity Universal Viewer Zero Footprint Client due to a potential mismatch between patient information and displayed images. This recall affects worldwide distribution, including the US.
What changed
GE Healthcare is recalling its Centricity Universal Viewer Zero Footprint Client (versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed) due to a defect where patient information shown in the viewer may not match the displayed images. This issue is classified as a Class II recall, indicating that use of the affected product may cause temporary or medically reversible adverse health consequences.
Healthcare providers using the affected GE Healthcare Centricity Universal Viewer software should be aware of this recall and potential for patient data discrepancies. While the recall is ongoing and distribution is worldwide, specific actions required by healthcare providers are not detailed in this notice. Compliance officers should ensure their facilities using this software are aware of the potential for image-to-patient data mismatch and consult GE Healthcare's advisories for any recommended mitigation steps to ensure patient safety and data integrity.
What to do next
- Review GE Healthcare advisories regarding the Centricity Universal Viewer recall
- Assess potential impact of patient information/image mismatch on clinical workflows
- Ensure awareness among clinical staff using the affected software
Archived snapshot
Mar 29, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
GE Healthcare
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1475-2026 · 20260311 · Ongoing
Product
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Reason for Recall
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,
Distribution
Worldwide distribution - US Nationwide and the countries of Belarus, Brazil, Canada, China, France, Georgia, Germany, India, Indonesia, Ireland, Is...
Source: openFDA Enforcement API
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