Device product
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.
Z-2251-2016
Product summary
- Event
- Event 74637
- Status
- Terminated
- Classification
- Class II
- Quantity
- 128
- Official record key
device-enforcement:Z-2251-2016
Official wording
Reason: It was discovered that both the new device and the predicate device failed to comply with performance standard.
Code information: All Raycell units with serial #'s 5000 and higher.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
It was discovered that both the new device and the predicate device failed to comply with performance standard.