Recall Z-1697-2019— Accuray Incorporated
Class II · Terminated
Class II FDA medical device recall by Accuray Incorporated, initiated 2018-04-10, terminated 2021-04-01. FDA's recall record names no specific 510(k) clearance for this event. Product: CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System. Reason: There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach..
- Recalling firm
- Accuray Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-10
- Terminated
- 2021-04-01
- Firm location
- Madison, WI, United States
Product description
CyberKnife VSI, Part Numbers: a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
Reason for recall
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
Data sourced from openFDA. This site is unofficial and independent of the FDA.