Recall Z-2654-2014— Varian Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2014-08-18, terminated 2015-07-30. It names one FDA 510(k) clearance: K133331. Product: 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.. 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..
- Recalling firm
- Varian Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-18
- Terminated
- 2015-07-30
- Firm location
- Palo Alto, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.