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.
Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
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.
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.
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.
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.
Identify if your EOSedge system has a serial number from the list provided in the recall notice.
The EOSedge system is used for acquiring two simultaneous orthogonal planar images of standing or seated patients at low radiation dose.
Check if your serial number matches the list: 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.
The recall does not specify a remedy, so no action is required beyond checking your serial number.
We’ve drafted a message you can send EOS Imaging to request your refund or repair — edit it as you like.
Subject: Recall Z-1415-2021 — EOS Imaging EOS Imaging Hello, I own a EOS Imaging that is covered by recall Z-1415-2021 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.
