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.
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).
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.
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.
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.
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.
Verify if Cross Enterprise Display is enabled and Workflow Manager is used to launch the viewer, as this combination may cause incorrect patient comparisons.
The device may show a different patient's comparison exam instead of the intended patient's when Cross Enterprise Display is enabled and Workflow Manager launches the viewer.
Check for the UDI code 00840682145794 or specific serial numbers listed in the recall notice.
No, the recall does not require stopping use. Users should verify settings to avoid incorrect patient comparisons.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1533-2021 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1533-2021 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
