RegWardenFDA facility compliance records
Company

EOS imaging

7 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 2 recalls; 2015: 1 recalls; 2017: 1 recalls; 2018: 1 recalls; 2020: 1 recalls1’122’13’141’15’161’171’18’191’20’21’22’23’24’25’26
  • Recalls (7)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2020-12-22
    Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
  • Class IITerminated2018-08-01
    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 ad…
  • Class IITerminated2017-05-30
    ROTH MOBELI grab handles could detach and patient could fall if the EOS system operator does not follow instructions. Before each use, the operator must examine the vacuum safety indicator to check the vacuum is monitored and sufficient and the grab handle correctly attached. Do…
  • Class IITerminated2015-02-17
    When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.
  • Class IITerminated2013-11-29
    Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
  • Class IITerminated2013-11-07
    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 acquisitio…
  • Class IITerminated2012-06-19
    It was discovered of several generator failures of the EOS System due to failure of its anode controller board that drives the rotation of the X-ray tube anode.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “EOS imaging — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10022240-eos-imaging/

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