Recall Z-0580-2014— EOS Imaging
Class II · Terminated
Class II FDA medical device recall by EOS Imaging, initiated 2013-11-29, terminated 2015-01-13. It names one FDA 510(k) clearance: K130395. Product: 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.. Reason: Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation.
- Recalling firm
- EOS Imaging
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-29
- Terminated
- 2015-01-13
- Firm location
- Paris France, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.