GE Healthcare recalls Centricity Universal Viewer Breast Imaging versions 6.0 SP4+ with specific workstations due to potential incorrect patient images during image switching, risking misdiagnosis.
When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not show images of the patient selected on UV, which could result in an incorrect diagnosis.
GE Healthcare is recalling certain versions of their Centricity Universal Viewer Breast Imaging system because switching between multiple image instances in Windows may cause patient images to not display correctly, potentially leading to misdiagnosis. This affects healthcare professionals using the system for breast imaging.
When switching between multiple UV instances in the Windows taskbar, the system may fail to display the correct patient images on mammo high resolution monitors. This could lead to misdiagnosis if the wrong images are used for analysis. The issue occurs only during specific switching actions in the software interface.
Healthcare professionals using the Centricity Universal Viewer Breast Imaging system with specific workstation versions are most at risk. The recall targets users who switch between multiple image instances in Windows taskbar.
Check if you have Centricity Universal Viewer Breast Imaging versions 6.0 SP4 or higher with Breast Imaging integrated with either IDI Mammo Workstation version 4.7.x or any version of SenoIris. The product is used by healthcare professionals for displaying medical images.
Identify if your Centricity Universal Viewer Breast Imaging is version 6.0 SP4 or higher with Breast Imaging integrated with IDI Mammo Workstation 4.7.x or SenoIris.
The recall occurs because switching between multiple UV instances in the Windows taskbar may cause patient images to not display correctly, potentially leading to misdiagnosis.
Check if your Centricity Universal Viewer Breast Imaging is version 6.0 SP4 or higher with Breast Imaging integrated with specific workstations. If so, contact GE Healthcare for guidance.
The recall record does not mention a specific fix or remedy; users are advised to check their product version and contact GE Healthcare.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0793-2019 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0793-2019 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.
