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
This recall has been terminated (originally issued April 10, 2018).
- Company
- Accuray Incorporated
- Recall Initiated
- April 10, 2018
- Terminated
- April 1, 2021
- Recall Number
- Z-1697-2019
- Quantity
- 43 units
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
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.
Distribution
US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand
Lot / Code Info
a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan Serial Numbers: C0281, C0307 b) 033000-010: CyberKnife VSI Robotic Radiosurgery System Serial Numbers: C0042, C0064, C0071, C0074, C0079, C0091, C0098, C0102, C0137, C0161, C0180, C0182, C0187, C0200, C0203, C0210, C0216, C0230, C0238, C0246, C0247, C0249, C0252, C0255, C0257, C0264, C0269, C0270, C0273, C0274, C0276, C0277, C0284, C0293, C0294, C0304, C0305, C0322, C0323, C0325, C0326
Root Cause
Other
Action Taken
The firm issued a field safety notice by letter on 04/10/2019. The letter explained the issue and provided safety instructions. All impacted customers with affected systems will be contacted to arrange for a software upgrade.