Lower riskMedical device recall · FDA · Published August 1, 2018
EOS Imaging sterEOS Workstation: Incorrect 3D Projections May Cause Clinical Errors
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.
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📍Recalling firmEOS Imaging4 Ieme Etage, 10 Rue Mercoeur · Paris, France
“EOS Imaging sterEOS Workstation: Incorrect 3D Projections May Cause Clinical Errors.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70226-eos-imaging-stereos-workstation-incorrect-3d-projections-may-cause-clinical. Based on FDA recall #Z-3188-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3188-2018%22&limit=1).
The FDA announced on Aug. 1, 2018, that EOS Imaging voluntarily recalled its sterEOS workstations due to potential incorrect 3D projections. The agency stated the recall was terminated and involved 17 units distributed nationwide.
How to tell if you have it
Brand: EOS Imaging
Product: sterEOS workstation
Quantity: 17 units
The hazard
The FDA said the hazard involves incorrect 3D projections when image pairs include a manually flipped secondary capture from a series with more than two images. These errors may lead to miscalculations of 3D clinical parameters, potentially contributing to incorrect clinical decisions or sub-optimal surgical interventions.
Context
GovInfoNow's records show EOS Imaging had one other recall on record since Dec. 22, 2020, specifically the EOSedge System Recall regarding inadequate image resizing and measurement errors. Other recent recalls of similar products include the PIE Medical Imaging 3mensio Workstation Software Recall (May 7, 2026), Philips Azurion Systems R3.0 Software Issues (Dec. 8, 2025), and GE Medical Systems Imactis CT-Navigation System Recall (Feb. 3, 2026).
How to tell if you have this one
Check if you own any EOS Imaging sterEOS workstations with software versions. All software versions are affected by this recall.
Brand
EOS Imaging
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify your sterEOS workstation software version to confirm if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-3188-2018 (August 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3188-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.