Accuray Incorporated: Medical Device Recall in 2019 - (Recall #: Z-1697-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 10, 2018

Date Posted: June 12, 2019

Recall Number: Z-1697-2019

Event ID: 82664

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.

Status: Terminated

Product Quantity: 43 units

Code Information:

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

Distribution Pattern:

US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand

Voluntary or Mandated:

Voluntary: Firm initiated