Recall Z-2251-2016 ยท MOT Irradiator, Blood To Prevent Graft Versus Host Disease
BEST THERATRONICS LTD.
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.
| Date | Jul 22, 2016 (initiated May 6, 2016) |
| Status | Terminated |
| Reason | It was discovered that both the new device and the predicate device failed to comply with performance standard. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Best Theratronics ( BTL) planned action to bring into compliance: BTL proposes that the repairs are to be completed during annual routine preventive maintenance visits at the user's site to minimize downtime, which disrupts the user's ability to irradiate blood. A standard repair kit has been developed. For further information, please contact Best Theratronics Customer Service at 1-866-792-8598 |
| Quantity | 128 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.