FDA Class II recall: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI.
S3 · 06 Dec 2016 · Accuray
Record
| Company | Accuray |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 06 Dec 2016 (day precision) |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | (recall, enforcement, or fleet-wide fault) |
| Scale | CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI |
| Confidence | high |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
FDA enforcement record (Class II, recall Z-0865-2017): Accuray has become aware of a potential safety issue involving the possibility of electric shock during maintenance activities from the lon Pump HV Power Supply at the back of the modulator cabinet. This issue is limited to certain G3, G4, and VSI models of the CyberKnife¿ Robot
Primary source
Publisher: openFDA enforcement · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 06 Dec 2016 | FDA Class II recall: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. | openFDA enforcement | openFDA enforcement |
Accuray other incidents timeline
Medical robotics context
recall context
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- 26 Feb 2021 - FDA Class II recall: CyberKnife Treatment Delivery System - Product Usage: indicated for im
- 27 Mar 2013 - FDA Class II recall: RoboCouch Patient Positioning System
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