FDA Medical Device Recalls (openFDA)
EOS Imaging: sterEOS workstation
- Recall number
- Z-3188-2018
- Recalling firm
- EOS Imaging
- Product
- sterEOS workstation
- Status
- Terminated
- Initiated
- 2018-08-01
- Posted
- not on file
- Terminated
- 2022-08-15
- Reason
- 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.
- Root cause
- Software design
- Action
- On August 1, 2018, a Field Safety Notice was issued to all impacted customers. Measures to be taken by users: EOS system and sterEOS review workstation users are requested not to apply manual symmetry to an image before saving a 2D secondary capture if more than two images are displayed in the EOS viewer mode or in 2D sterEOS. Users of the 3D sterEOS review workstation are requested to check that 3D projections associated with pelvic parameters match when a 3D image is created from a pair of images belonging to a series of more than two images. INSTRUCTIONS FOR END USERS: 1) Please read the field safety notice. 2) Follow the instructions provided in this field safety notice. 3) Please transfer this notice to whomever needs to be informed within your organization or in any organization to which the sterEOS review workstation may have been transferred. INSTRUCTIONS FOR DISTRIBUTORS: 1) Please read the field safety notice. 2) Please transfer all the documentation relating to the field safety notice to your customers in the field and keep proof of delivery of this documentation. Please regularly submit your customers' response rate to EOS imaging by email (regulatory@eos-imaging.com). EOS imaging needs this proof to monitor the evolution of corrective measures.
- Quantity
- 17 units
- Distribution
- US nationwide
- Lot, serial or model codes
- All software versions are impacted
- 510(k) numbers
- ["K172346"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3006165260
- Firm city
- Paris
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28