Eos Imaging
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000000502 FEI 3006165260
Eos Imaging is a medical device manufacturer based in France, with 31 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I; EU Class IIa and I) and 8 FDA recalls as of 13 Nov 2026.
- Devices
- 31
- Registrations
- EUDAMEDFDA
- FDA recalls
- 8
Registry facts
- Registries
- FDA GUDID 22
- FDA 510(k) 8
- EUDAMED 5
- Device classes
- FDA Class II 24
- EU Class IIa 3
- EU Class I 2
- FDA Class I 2
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN FR-MF-000000502
- FDA FEI 3006165260
- DUNS 762320968
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment, FDA recalls
Catalogue
Search and filter all 31 devicesCompany details
- EUDAMED SRN
- FR-MF-000000502
- FDA FEI number
- 3006165260
- DUNS number
- 762320968
- EU VAT number
- FR09349694893
- EUDAMED status
- Active since 2023
- EUDAMED registered name
- EOS imaging
- Registered address
- 32, rue Blanche, 75009, Paris, France
- Phone
- 8669335301
- PRRC contact
- Mathilde MASUREL
FDA recalls
Recalls initiated per year
- 2017 1
- 2018 1
- 2019 0
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 22 Dec 2020 Z-1415-2021 Class II Terminated Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior).
2018
- 1 Aug 2018 Z-3188-2018 Class II Terminated 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.
2017
- 30 May 2017 Z-2626-2017 Class II Terminated 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 not use grab handles to help patient up. The handles are only for stabilizing the patients hand or arm in the EOS cabin.
2015
- 17 Feb 2015 Z-1460-2015 Class II Terminated 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.
2013
- 29 Nov 2013 Z-0580-2014 Class II Terminated Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
- 7 Nov 2013 Z-0529-2014 Class II Terminated 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.
2012
- 19 Jun 2012 Z-2072-2012 Class II Terminated 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.
2011
- 13 Apr 2011 Z-2692-2011 Unclassified (pre-2012) Terminated Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor
during printing. T
Full distribution text
- 13 Apr 2011 Z-2692-2011 Unclassified (pre-2012) Terminated Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor
during printing. T
FDA establishments
- Eos Imaging, Inc. US
Frequently asked questions
How many devices does EOS IMAGING have in the registry?
The registry currently lists 31 devices for EOS IMAGING. Devices recorded under merged duplicate company entries are counted once.
Which registries list EOS IMAGING's devices?
Among its 31 most recently registered devices, EOS IMAGING has devices listed in EUDAMED (5 devices), FDA 510(k) (8 devices) and FDA GUDID (22 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do EOS IMAGING's devices fall under?
Among its 31 most recently registered devices, the classes recorded for EOS IMAGING's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for EOS IMAGING?
FDA recall records list 8 recalls initiated by EOS IMAGING, the most recent initiated on 22 Dec 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from EOS IMAGING in the registry?
The most recently registered devices listed for EOS IMAGING include spineEOS 6.x, AutoDensity 1.3, VEA Align 4.x and EOS System.
Which FDA establishments are linked to EOS IMAGING?
1 FDA establishment is linked to EOS IMAGING in the registry; they are listed on the company page.