FDA recall Z-1696-2019

Accuray Incorporated · Class II · device

Product

CyberKnife M6, Part Numbers: a) 0660000: CyberKnife Treatment Delivery System b) 053101-010: CyberKnife M6 FI Treatment Delivery System c) 053201-010: CyberKnife M6 FM Treatment Delivery System d) 053301-010: CyberKnife M6 FIM Treatment Delivery System e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System f) 053501-010: CyberKnife Matrix Tier 2 TDS

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

Key facts

Status: Terminated
Initiation date: 2018-04-10
Report date: 2019-06-12
Termination date: 2021-04-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Madison, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1696-2019