EOS Imaging recalls sterEOS workstation software versions due to potential 3D projection errors affecting clinical decisions. All software versions are impacted.
3D projections may be incorrect when the pair of images used is a secondary capture generated from a series containing more than two images, where one of the images has been manually flipped. Projection errors may lead to errors in calculation of 3D clinical parameters when adjusting the position, size and shape of the 3D objects used. Incorrect clinical parameters can be a contributing factor in incorrect clinical decisions, or sub-optimal surgical interventions.
EOS Imaging has recalled all versions of their sterEOS workstation software. Incorrect 3:1 projections could lead to wrong clinical decisions during surgery if the software misinterprets image sequences.
The software may produce incorrect 3D projections when processing certain image sequences. This can cause errors in calculating clinical parameters like object size and shape. Incorrect parameters might lead to poor surgical outcomes or wrong treatment decisions.
Medical professionals using EOS Imaging sterEOS workstations for 3D medical imaging are most at risk. The recall affects all software versions of the device.
Check if you own any EOS Imaging sterEOS workstations with software versions. All software versions are affected by this recall.
Identify your sterEOS workstation software version to confirm if it is affected by this recall.
Yes, all software versions of the sterEOS workstation are impacted by this recall.
Incorrect 3D projections might lead to errors in clinical decisions, potentially affecting surgical outcomes.
No, the recall does not require immediate discontinuation. Users should check their software version and follow the provided steps.
We’ve drafted a message you can send EOS Imaging to request your refund or repair — edit it as you like.
Subject: Recall Z-3188-2018 — EOS Imaging EOS Imaging Hello, I own a EOS Imaging that is covered by recall Z-3188-2018 from EOS Imaging. 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.
