Novarad recalls specific versions of NovaPACS Diagnostic Viewer software due to potential inaccuracies in cross-localization of asymmetrical images, which could affect diagnostic accuracy.
The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open.
Novarad is recalling specific versions of its NovaPACS Diagnostic Viewer software. The issue could cause inaccurate placement of reference lines when using cross-localization features with asymmetrical images, potentially affecting diagnostic accuracy.
The software may place reference lines inaccurately when cross-localizing images from modalities that produce asymmetrical images. This could lead to misdiagnosis if reference lines are misaligned during image analysis.
Users of NovaPACS Diagnostic Viewer software versions 8.6.8 through 8.7.8 are affected. Medical professionals using the software for imaging diagnostics are at the highest risk.
Check if you have NovaPACS Diagnostic Viewer software versions 8.6.8, 8.6.9, 8.6.11, 8.6.12, 8.6.14, 8.7.4, 8.7.6, or 8.7.8. The software retrieves and displays images from CT, MRI, ultrasound, and other medical imaging modalities.
Identify your NovaPACS version by checking the software's version number in the application settings.
Update to a newer version of NovaPACS that is not listed in the recall if available.
NovaPACS versions 8.6.8, 8.6.9, 8.6.11, 8.6.12, 8.6.14, 8.7.4, 8.7.6, and 8.7.8 are affected.
The issue may cause inaccurate placement of reference lines when cross-localizing images from asymmetrical modalities, potentially leading to misdiagnosis.
The recall does not specify a fix; users should update to a newer version of NovaPACS if available.
We’ve drafted a message you can send Novarad to request your refund or repair — edit it as you like.
Subject: Recall Z-2956-2020 — Novarad Novarad Hello, I own a Novarad that is covered by recall Z-2956-2020 from Novarad. 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.
