Recall Z-1697-2019 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
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
| Date | Apr 10, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 43 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.