Accuray CyberKnife System Medical Physicist — Class II medical device recall Z-1126-2013
Terminated recall by Accuray Incorporated, reported 2013-04-24, distributed nationwide. A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collim
| Recall number | Z-1126-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accuray Incorporated, Sunnyvale, CA, United States |
| Recall initiated | 2013-03-19 |
| Classified | 2013-04-16 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-10-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, CZ, DE, ES, FI, FR, GB, GR, IN, IT, JP, KR, MX, PL, RU, SA, TR |
| Quantity | 176 units |
Product
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
Reason for recall
A defect on the master-side connector block of the pneumatic tool changer could introduce a tilt in the collimator housings, resulting in a potential shift to the central axis of the radiation beam. The issue could pose significant clinical impact to plans created using the smallest collimators.
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-1126-2013. 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.