CyberKnife Robotic Radiosurgery System with the first generation IRIS… — Class II medical device recall Z-0218-2015
Terminated recall by Accuray Incorporated, reported 2014-11-26, distributed in AL, AZ, CA, CO, CT, DC, DE, FL…. Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the
| Recall number | Z-0218-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Sunnyvale, CA, United States |
| Recall initiated | 2014-10-31 |
| Classified | 2014-11-14 |
| Reported by FDA | 2014-11-26 |
| Terminated | 2015-02-20 |
| Distributed | AL, AZ, CA, CO, CT, DC, DE, FL, IL, IN, KS, MA, MI, MO, MS, NC, NJ, NV, NY, OH, OK, PA, RI, TN, TX, WI |
| Countries outside the US | BE, CA, CH, DE, ES, FR, GB, GR, IN, IT, KR, MX, PL, RU, SA, TR |
| Quantity | 84 devices |
| Reason classes | software |
| Serial numbers | C0034, C0043, C0047, C0055, C0057, C0059, C0061, C0068, C0071, C0072, C0090, C0092, C0093, C0094, C0101, C0112, C0118, C0131, C0134, C0137, C0141, C0143, C0144, C0151, C0158 and 58 more |
| Model numbers | 054000-0001 |
Product
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Reason for recall
Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator.
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-0218-2015. 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.