C-Series High Energy Linear Accelerator — Class II medical device recall Z-2567-2014
Terminated recall by Varian Medical Systems, Inc., reported 2014-09-24, distributed nationwide. Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV pho
| Recall number | Z-2567-2014 |
|---|---|
| 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 | 2014-06-17 |
| Classified | 2014-09-12 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2018-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CR, CZ, DE, DK, DO, DZ, EC, EE, ES, FI, FR, GB, HK, HU, ID, IE, IL, IN, IQ, IS, IT, JP, KR, LK, LU, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, TH, TR, TW, UA, VE, ZA |
| Quantity | 3,416 |
| Serial numbers | H140001, H140011, H140018, H140025, H140026, H140027, H140029, H140036, H140038, H140039, H140045, H140046, H140047, H140048, H140058, H140062, H140067, H140070, H140071, H140072, H140076, H140077, H140078, H140079, H140086 and 475 more |
| Model numbers | H14, H27, H29 |
Product
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
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-2567-2014. 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.