Drug recall
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The…
FDA recall event 69645 · Class II · Accuray Incorporated
Key facts
| Event ID | 69645 |
|---|---|
| Recall numbers | Z-0218-2015 |
| Recalling firm | Accuray Incorporated |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 31, 2014 |
| Report date | Nov 26, 2014 |
| Termination date | Feb 20, 2015 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 1000123585 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: