Class II — EOS Imaging
| Recalling firm | EOS imaging |
|---|---|
| Registered facility | EOS imaging (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | sterEOS workstation |
| Quantity | 17 units |
| Distribution | US nationwide |
| Initiated | 2018-08-01 |
| Classified | 2018-09-18 |
| Terminated | 2022-08-15 |
| Recall number | Z-3188-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — EOS Imaging (Z-3188-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80938/
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