EOSedge System Recall: Inadequate Image Resizing and Measurement Errors
EOS Imaging recalls specific EOSedge systems that may produce inaccurate images if patient is not positioned correctly during scans. Affected units can be identified by serial numbers listed in the recall notice.
Lower-risk recall
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
Contact the company
What happened, in plain English
EOS Imaging is recalling certain EOSedge systems that may produce inaccurate images if the patient is not positioned correctly during scans. This could lead to incorrect measurements and potentially affect medical decisions. Read more at govinfonow.com/recall/63626-eosedge-system-recall-inadequate-image-resizing-and-measurement-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/63626-eosedge-system-recall-inadequate-image-resizing-and-measurement-errors · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1415-2021
Cite this page
“EOSedge System Recall: Inadequate Image Resizing and Measurement Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63626-eosedge-system-recall-inadequate-image-resizing-and-measurement-errors. Based on FDA recall #Z-1415-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1415-2021%22&limit=1).
Why it’s dangerous
The system may produce inaccurate images and measurement errors if the patient is not positioned correctly relative to the X-ray machine. This can happen when the patient's orientation differs from the standard Antero-Posterior (AP) position during scans.
Who’s affected
Patients using the EOSedge system for medical imaging, particularly those undergoing scans where precise measurements are critical. Healthcare providers who use the system for diagnostic purposes are most at risk.
How to tell if you have this one
Check for serial numbers listed in the recall: 8.1912.1008, 8.2001.1010, 8.2001.1011, 8.2002.1012, 8.1907.1005, 8.1909.1006, 8.2005.1014, 8.1905.1004, 8.1911.1007, 8.1912.1009, and 8.2006.1016.
- Brand
EOS Imaging- Category
Medical device
What to do — step by step
Check Serial Numbers
Identify if your EOSedge system has a serial number from the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 2 states.
FDA distribution: “Distributed nationwide to MN, OH and internationally to Australia, Canada, Germany, Spain, and France” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Minnesota, Ohio.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the EOSedge system used for?
The EOSedge system is used for acquiring two simultaneous orthogonal planar images of standing or seated patients at low radiation dose.
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Where this comes from
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-1415-2021 (December 22, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1415-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.