Recall Z-0976-04 ยท JAQ System, Applicator, Radionuclide, Remote-Controlled
Varian Medical Systems
VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series. Manufactured by Varian Medical Systems
| Date | Jul 20, 2004 (initiated May 4, 2004) |
| Status | Terminated |
| Reason | Manufacturer of brachytherapy instrument issued a Customer Technical Bulletin to clarify instructions for use of the radiation treatment medical device by healthcare practitioners. |
| Root cause | Other |
| Action | The recalling firm notified end users by letter and Customer Technical Bulletin on 5/4/04. The notification informed users not to use the Emergency retract hand wheel to recover a dummy wire and to reinforce the instructions already in the procedures that in the event of an Active wire becoming stuck out, the user should not turn the emergency retract hand wheel in excess of 20 times, or until the wire has parked and the radiation alarm has silenced. Advised of proper procedures for retracting the active wire and a warning concerning excessive turning of the emergency retract handwheel. The no |
| Quantity | 249 |
| Distribution | The medical devices for correction had been distributed to medical facilities nationwide and internationally. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.