Z-2251-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2016
- Initiation Date
- May 6, 2016
- Termination Date
- August 1, 2017
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 128
Product Description
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
Reason for Recall
It was discovered that both the new device and the predicate device failed to comply with performance standard.
Distribution Pattern
Nationwide
Code Information
All Raycell units with serial #'s 5000 and higher.