Recall Z-2654-2014 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc.
4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
| Date | Sep 16, 2014 (initiated Aug 18, 2014) |
| Status | Terminated |
| Reason | Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV. |
| Root cause | Software design |
| Action | Varian issued an Urgent Medical Device Correction Notification letter dated August 19, 2014, to all affected sites. The letter informed users of the specific product and versions numbers as well as the issue. A list of third party systems that perform verification and communicate authorizations via ADI are included in Table 1 of the letter. The issue is only now to occur with the ExacTract positioning system in combination with a C-Series HE linac BCCV. User recommended actions are provided for users using auxiliary devices requiring ADI interface and for users performing SRS/SBRT. Varian ha |
| Quantity | 512 affected devices |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Brazil, Canada, Chili, China, Columbia, Czech Republic, France, Georgia, Germany, hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Macau, Malaysia, Mexico, Netherland,s Portugal, Qutar, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133331 | 4D INTEGRATED TREATMENT CONSOLE Varian Medical Systems, Inc., Jan 27, 2014 |