FDA
RAD SOURCE RS 3000 Blood Irradiator Three Bag Option
The firm completed a cooling system retrofit to preclude overheating and failure.
The firm e-mailed a notification on May 9, 2002 to its consignees giving them instructions on using additional radiation indictors to assure that the blood units were correctly irradiated. They also initiated a cooling tube retrofit of all units on that date and this was completed on 8/13/2002.