| Class 2 Device Recall CyberKnife Robotic Radiosurgery System | |
Date Initiated by Firm | March 21, 2007 |
Date Posted | December 12, 2007 |
Recall Status1 |
Terminated 3 on December 26, 2007 |
Recall Number | Z-0364-2008 |
Recall Event ID |
38346 |
510(K)Number | K052325 |
Product Classification |
Radiation Therapy Treatment Planning System - Product Code MUJ
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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/ Manufacturer |
Accuray Inc 1310 Chesapeake Ter Sunnyvale CA 94089-1100
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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 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = MUJ
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