Z-0529-2014 Class II Terminated
FDA device recall Z-0529-2014 was initiated by EOS Imaging on November 7, 2013 and is designated Class II. Reason for recall: EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual colli… The recall status is terminated (terminated January 27, 2015). Affected quantity: 22 EOS systems are installed in US.
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2014
- Initiation Date
- November 7, 2013
- Termination Date
- January 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 EOS systems are installed in US
Product Description
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Reason for Recall
EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.
Distribution Pattern
Nationwide Distribution
Code Information
EOS System