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.
FDA Recall Z-2251-2016 · Posted 2016-07-22
Recalling FirmBEST THERATRONICS LTD.
Recall StatusTerminated
Product CodeMOT
Date Initiated2016-05-06
Date Terminated2017-08-01
Product Quantity128
Reason for Recall
It was discovered that both the new device and the predicate device failed to comply with performance standard.
Firm 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
Root Cause
Radiation Control for Health and Safety Act
Distribution Pattern
Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.