Date Initiated by Firm | July 17, 2009 |
Date Posted | September 22, 2009 |
Recall Status1 |
Terminated 3 on November 27, 2010 |
Recall Number | Z-2231-2009 |
Recall Event ID |
53045 |
510(K)Number | K071873 |
Product Classification |
radiation therapy treatment planning system - Product Code MUJ
|
Product | Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. |
Code Information |
Model number H48, code number H484023. |
Recalling Firm/ Manufacturer |
Varian Medical Systems Oncology Systems 911 Hansen Way Palo Alto CA 94304-1028
|
For Additional Information Contact | 650-424-5731 |
Manufacturer Reason for Recall | Software Issue/Mistreatment Potential-- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered. |
FDA Determined Cause 2 | Software design |
Action | Varian Medical Systems Recall initiated on July 17, 2009. A product notification letter was distributed to the affected user, with a description of the problem and user corrective action steps. The letter will be distributed to the sales, marketing and service organizations via certified mail. A software correction is planned. |
Quantity in Commerce | 1 |
Distribution | Product was distributed to one user in Texas |
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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