GE Healthcare Centricity Universal Viewer Recall: Patient Comparison Exam Risk
GE Healthcare recalls Centricity Universal Viewer devices that may show incorrect patient comparisons when Cross Enterprise Display is enabled and Workflow Manager launches the viewer. Affected units have specific serial numbers and UDI codes.
Lower-risk recall
When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s).
Contact the company
What happened, in plain English
GE Healthcare is recalling certain Centricity Universal Viewers that could display incorrect patient comparison exams when specific software settings are used. This could lead to misdiagnosis if healthcare providers rely on the viewer's output without verifying the patient data. Read more at govinfonow.com/recall/63033-ge-healthcare-centricity-universal-viewer-recall-patient-comparison-exam-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/63033-ge-healthcare-centricity-universal-viewer-recall-patient-comparison-exam-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1533-2021
Cite this page
“GE Healthcare Centricity Universal Viewer Recall: Patient Comparison Exam Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63033-ge-healthcare-centricity-universal-viewer-recall-patient-comparison-exam-risk. Based on FDA recall #Z-1533-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1533-2021%22&limit=1).
Why it’s dangerous
When the Cross Enterprise Display option is enabled and Workflow Manager launches the viewer, the device may show a different patient's comparison exam instead of the intended patient's. This could cause misdiagnosis if healthcare providers rely on the viewer's output without verifying the patient data.
Who’s affected
Healthcare facilities using the Centricity Universal Viewer with specific serial numbers or UDI codes are most at risk. Patients using the device for medical imaging may be affected if their exam data is misinterpreted.
How to tell if you have this one
Check for the UDI code 00840682145794 or specific serial numbers listed in the recall notice. The device is used for medical imaging and diagnostic interpretation in healthcare settings.
- Brand
GE Healthcare- Category
Medical device
What to do — step by step
Check Device Settings
Verify if Cross Enterprise Display is enabled and Workflow Manager is used to launch the viewer, as this combination may cause incorrect patient comparisons.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
FDA distribution: “Distributed nationwide to AR, CA, CO, DE, FL, IL, IN, LA, ME, NE, NJ, NV, NY, PA, SC, TX and internationally to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Colorado, Delaware, Florida, Illinois, Indiana, Louisiana, Maine, Nebraska, Nevada, New Jersey, New York, Pennsylvania, South Carolina, Texas.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the device?
No, the recall does not require stopping use. Users should verify settings to avoid incorrect patient comparisons.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1533-2021 (March 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1533-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.