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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 Device Recall CyberKnife Robotic Radiosurgery Systemsee related information
Date Initiated by FirmMarch 21, 2007
Date PostedDecember 12, 2007
Recall Status1 Terminated 3 on December 26, 2007
Recall NumberZ-0364-2008
Recall Event ID 38346
510(K)NumberK052325 
Product Classification Radiation Therapy Treatment Planning System - Product Code MUJ
ProductAccuray, 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/
Manufacturer		 Accuray Inc
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact
408-716-4600
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		Software design
ActionThe 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 Commerce25 units
DistributionWorldwide 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MUJ
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