CLASS II Device recall · Reported 1 Jan 2014 · FDA Enforcement Report
steroEOS Workstation recalled by EOS Imaging
EOS Imaging is recalling steroEOS Workstation, distributed nationwide in the US. The recall was initiated on 29 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0580-2014
- FDA event ID
- 66980
- Recalling firm
- EOS Imaging, Paris France, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Nov 2013
- FDA classified
- 26 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 29 Nov 2013 | Recall initiated by company | |
| 26 Dec 2013 | Classified by FDA | +27 days |
| 1 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Where it was distributed
USA Nationwide Distribution
Questions about this recall
Is steroEOS Workstation recalled?
Yes. EOS Imaging recalled steroEOS Workstation on 29 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0580-2014.
Why was it recalled?
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
Which lots are affected?
Software versions: 1.3, 1.4 and 1.5
Where was it sold?
USA Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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