GE Healthcare recalls Centricity Universal Viewer 6.0 SP10+ due to potential misdiagnosis from incorrect grayscale measurements in images with varying pixel sizes. Affected units may require correction to ensure accurate medical imaging.
Centricity Universal Viewer measurements saved into a DICOM Grayscale Presentation State are incorrect in subsequent views for exams containing series with different pixel sizes and may lead to a potential misdiagnosis.
GE Healthcare is recalling Centricity Universal Viewer 6.0 software versions 6.0 SP10 or higher because measurements saved in medical images can be incorrect when viewing images with different pixel sizes. This could lead to misdiagnosis if not corrected.
The software saves medical image measurements in a way that can become inaccurate when viewing images with different pixel sizes. This inaccuracy might cause doctors to misinterpret the images, potentially leading to incorrect diagnoses.
Healthcare providers using the Centricity Universal Viewer 6.0 software versions 6.0 SP10 or higher for medical imaging. Patients whose imaging results are affected by incorrect measurements may be at risk.
Check if your device shows 'Centricity Universal Viewer 6.0' with model number 2088026-9XX. Versions 6.0 SP10 or higher are affected.
Verify your software version by checking the device settings or documentation for 'Centricity Universal Viewer 6.0' with model number 2088026-9XX.
The recall is for potential misdiagnosis due to incorrect image measurements, but the risk is low as it only affects specific image types and requires correction.
Check if your device shows 'Centricity Universal Viewer 6.0' with model number 2088026-9XX and software version 6.0 SP10 or higher.
The recall does not specify a remedy, so contact GE Healthcare directly for guidance on correcting the issue.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0819-2020 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0819-2020 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.
