Date Initiated by Firm | October 31, 2011 |
Date Posted | January 11, 2012 |
Recall Status1 |
Terminated 3 on June 06, 2014 |
Recall Number | Z-0370-2012 |
Recall Event ID |
60441 |
510(K)Number | K091492 |
Product Classification |
System, planning, radiation therapy treatment - Product Code MUJ
|
Product | Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An
Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart
module), Reference/FSCA Identifier: CP-05277, Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA.
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. |
Code Information |
CODES: All codes from H480005 through H48C896 |
Recalling Firm/ Manufacturer |
Varian Medical Systems, Inc. Oncology Systems 911 Hansen Way Palo Alto CA 94304-1028
|
For Additional Information Contact | Peter J. Coronado 650-424-5731 |
Manufacturer Reason for Recall | An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point
in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction
in Eclipse.
|
FDA Determined Cause 2 | Device Design |
Action | Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" dated October 31, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Varian has corrected the issue and will contact customers to schedule installation of the corrected version of the system. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice.
. |
Distribution | Worldwide Distribution. |
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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