Z-0580-2014 Class II Terminated
FDA device recall Z-0580-2014 was initiated by EOS Imaging on November 29, 2013 and is designated Class II. 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 The recall status is terminated (terminated January 13, 2015). Affected quantity: 36 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2014
- Initiation Date
- November 29, 2013
- Termination Date
- January 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 units
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
Distribution Pattern
USA Nationwide Distribution
Code Information
Software versions: 1.3, 1.4 and 1.5