Merge Healthcare recalls specific versions of their OrthoPACS software due to potential image display errors when using mammography stacked scrolling features. Affected versions include 7.3, 7.3.1, 8.0, and 8.0.1.
Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
Merge Healthcare is recalling specific versions of their OrthoPACS medical imaging software. The recall is due to a potential issue where thumbnails might not display in reverse chronological order or images may not scroll properly when mammography stacked scrolling is enabled. This could affect how medical professionals view and compare imaging results.
The software may display thumbnails out of order or prevent images from scrolling backward when mammography stacked scrolling is enabled. This could lead to confusion in viewing medical images, but does not pose a direct safety risk to users.
Medical professionals using Merge OrthoPACS software versions 7.3, 7.3.1, 8.0, and 8.0.1 for mammography imaging are most at risk. The recall affects users who rely on the software's image manipulation tools for viewing and comparing medical images.
Check if your software version is 7.3, 7.3.1, 8.0, or 8.0.1. The UDI numbers are (01)00842000100706 for 7.3/7.3.1 and (01)00842000100775 for 8.0/8.0.1.
Verify your OrthoPACS version by checking the software's version number or UDI numbers listed in the recall notice.
The recall is due to potential issues with thumbnail display and image scrolling order when mammography stacked scrolling is enabled, which could affect how medical images are viewed.
Versions 7.3, 7.3.1, 8.0, and 8.0.1 of Merge OrthoPACS software are affected.
The recall does not require immediate action, but you should check your software version to ensure you are not using an affected version.
We’ve drafted a message you can send Merge Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2063-2019 — Merge Healthcare Merge Healthcare Hello, I own a Merge Healthcare that is covered by recall Z-2063-2019 from Merge 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.
