C-Series: Clinac — Class II medical device recall Z-0439-2014
Terminated recall by Varian Medical Systems, Inc., reported 2013-12-11, distributed nationwide. This correction is to notify users that a solution to a previous correction has been developed and Varians rep
| Recall number | Z-0439-2014 |
|---|---|
| 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 | 2013-10-24 |
| Classified | 2013-12-03 |
| Reported by FDA | 2013-12-11 |
| Terminated | 2016-01-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HU, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LB, LU, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SI, SK, TH, TN, TR, TT, TW, UA, VE, VN, ZA |
| Quantity | 3,809 devices |
| Serial numbers | H140001, H140011, H140018, H140029, H140038, H140039, H140043, H140047, H140048, H140058, H140062, H140067, H140070, H140071, H140074, H140076, H140077, H140078, H140079, H140086, H140088, H140090, H140096, H140097, H140101 and 475 more |
| Model numbers | H27, H29, HL4 |
Product
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Reason for recall
This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
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-0439-2014. 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.