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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife Robotic Radiosurgery System

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 Class 2 Recall
CyberKnife Robotic Radiosurgery System
see related information
Date Posted December 12, 2007
Recall Status1 Terminated on December 26, 2007
Recall Number Z-0364-2008
Recall Event ID 38346
Premarket Notification
510(K) Number
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Accuray, Multiplan Treatment Planning Software, Versions 2.0, 2.0.1 .6, 1.6.1, 1.6..1 or 1.6.3., Accuray, Sunnyvale, CA 94089.
Code Information Software Versions 1.6, 1.6.1, 1.6.3, 2.0, 2.0.1, and below.
Recalling Firm/
Accuray Inc
1310 Chesapeake Ter
Sunnyvale, California 94089-1100
Manufacturer Reason
for Recall
Software problem - Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation.
FDA Determined
Cause 2
DESIGN: Software Design
Action The firm issued an Urgent Advisory Notification on March 20, 2007, notifying users to only import axial sliced MR image series for treatment planning. Users should not import sagittal, oblique or coronal images series until further notice. The firm intends to issue a software patch to correct the problem and will contact user regarding resolution. Users can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com.
Quantity in Commerce 25 units
Distribution Worldwide Distribution - USA including states of MD, CA, FL, WA, LA, IL, IN, MI, MN, NC, NJ, OK, WI, and OH, and countries of Korea, Greece, Germany, France, and Turkey.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = ACCURAY INCORPORATED