Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0529-2014 — EOS System X- ray beam Digital radiography system used in general radiographic examinations.

U.S. FDA — Device Enforcement · France · 2013-11-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0529-2014
Date of alert
2013-11-07
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
EOS Imaging
Product category
device
Product type
Devices
Reported risk: EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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