FDA Class II recall: CyberKnife Treatment Delivery System - Product Usage: indicated for im
S3 · 26 Feb 2021 · Accuray
Record
| Company | Accuray |
| Industry | Medical robotics |
| Type(s) | recall |
| Date | 26 Feb 2021 (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 Treatment Delivery System - Product Usage: indica |
| Confidence | high |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
FDA enforcement record (Class II, recall Z-1272-2021): The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.
Primary source
Publisher: openFDA enforcement · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 26 Feb 2021 | FDA Class II recall: CyberKnife Treatment Delivery System - Product Usage: indicated for im | openFDA enforcement | openFDA enforcement |
Accuray other incidents timeline
Medical robotics context
recall context
Accuray industry position
Related incidents
Other Accuray entries
- 06 Dec 2016 - FDA Class II recall: CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI.
- 27 Mar 2013 - FDA Class II recall: RoboCouch Patient Positioning System
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