Class II — Accuray Incorporated
| Recalling firm | Accuray Incorporated |
|---|---|
| Registered facility | Accuray Incorporated (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 84 devices subject to correction. |
| Distribution | Worldwide Distribution - USA including CA, MS, FL, AZ, DC, TX, CO, CT, IL, WI, RI, NV, OK, MA, AL, NY, MO, NC, TN, PA, DE, NJ, MI, IN, KS, OH. Foreign distribution to Turkey, Switzerland, Spain, Saudi Arabia, Russia, Poland, Mexico and Korea, Italy, India, Greece, Germany, France, England, Canada, and Belgium. |
| Initiated | 2014-10-31 |
| Classified | 2014-11-14 |
| Terminated | 2015-02-20 |
| Recall number | Z-0218-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Accuray Incorporated (Z-0218-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69645/
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