sterEOS workstation — Class II medical device recall Z-3188-2018
Terminated recall by EOS Imaging, reported 2018-09-26, distributed nationwide. 3D projections may be incorrect when the pair of images used is a secondary capture generated from a series co
| Recall number | Z-3188-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EOS Imaging, Paris, N/A, France |
| Recall initiated | 2018-08-01 |
| Classified | 2018-09-18 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2022-08-15 |
| Distributed | Nationwide (US) |
| Quantity | 17 units |
Product
sterEOS workstation
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3188-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.