4D Integrated Treatment Console — Class II medical device recall Z-2654-2014
Terminated recall by Varian Medical Systems, Inc., reported 2014-09-24, distributed nationwide. Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on be
| Recall number | Z-2654-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc., Palo Alto, CA, United States |
| Recall initiated | 2014-08-18 |
| Classified | 2014-09-16 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-07-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CH, CN, CZ, DE, ES, FR, GB, HK, HU, ID, IE, IL, IN, IT, JP, KR, LK, LT, LV, MX, MY, PT, RU, SG, SI, TH, TW, UA |
| Quantity | 512 affected |
| Serial numbers | H293495, H510004, H510126, H510340, H510408, H510451, H510565, H510624, H510732, H510794, H510855, H510866, H510889, H510915, H510942, H510966, H511002, H511012, H511152, H511275, H511276, H511303, H511313, H511330, H511399 and 475 more |
| Model numbers | H51 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2654-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.