Varian High Energy Clinacs — Class II medical device recall Z-1325-2013
Terminated recall by Varian Medical Systems, Inc. Oncology Systems, reported 2013-05-22, distributed nationwide. Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry
| Recall number | Z-1325-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, United States |
| Recall initiated | 2011-05-31 |
| Classified | 2013-05-14 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2013-05-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BG, BH, BR, CA, CH, CL, CN, CY, DE, DK, DO, DZ, EC, EE, EG, ES, FI, GB, GR, HK, ID, IE, IL, IN, IT, JP, KR, KW, LB, LK, LT, LV, MX, MY, NL, NO, NP, NZ, OM, PA, PE, PK, PL, PT, QA, RO, RS, RU, SE, SG, SK, TH, TN, TR, TT, TW, UA, UY, VN, ZA |
| Quantity | 3,943 units |
| Model numbers | H14, H27, H29 |
Product
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
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-1325-2013. 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.