FDA Device recall Z-2654-2014
4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear…
- FDA Device
- Class II
- terminated
- Published 2014-09-24
On 2014-09-24 the FDA classified a Class II recall of 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear… by Varian Medical Systems, citing 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 BrainL….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2654-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-18 |
| Published | 2014-09-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Varian Medical Systems |
| Distribution | US |
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.
Identifiers
| code_info | Model number H51; Serial numbers: H51B429 H514517 H511720 H514463 H511002 H513925 H514115 H510855 H515068 H514544 H51…Model number H51; Serial numbers: H51B429 H514517 H511720 H514463 H511002 H513925 H514115 H510855 H515068 H514544 H512492 H515879 H515060 H513064 H514438 H514022 H512957 H514553 H515102 H515991 H515511 H51B421 H515106 H514189 H513551 H513009 H515033 H51B568 H515804 H51B611 H515004 H513477 H513133 H513562 H510966 H515691 H513894 H515363 H513801 H51B362 H518326 H518191 H514863 H513889 H514050 H515619 H515282 H515413 H51B240 H515815 H51B204 H512299 H513438 H51B233 H510451 H512146 H512507 H515601 H513692 H51B136 H51B479 H515247 H513069 H514278 H515588 H51B948 H514126 H512828 H513786 H515095 H513002 H515583 H51B100 H513891 H513591 H515657 H512829 H515800 H513300 H513249 H515249 H515819 H514365 H513127 H515064 H515849 H514464 H515998 H512287 H511424 H515561 H515454 H51B328 H51A050 H515727 H514433 H514282 H514186 H510889 H518106 H515031 H513826 H515251 H51B656 H512357 H514479 H512513 H51B585 H518138 H515947 H513772 H515336 H515759 H510340 H515231 H511399 H514336 H513353 H515446 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2654-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.