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U.S. Department of Health and Human Services

Class 2 Device Recall Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22

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 Class 2 Recall
Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22
see related information
Date Posted January 15, 2009
Recall Status1 Open
Recall Number Z-0855-2009
Recall Event ID 50143
Premarket Notification
510(K) Number
K071873 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22, model number H48, manufactured by Varian Medical Systems, Inc., Palo Alto, CA. Indicated for planning proton treatment of neoplasms of the eye.
Code Information Model number H48, serial numbers H480016, H480051, H480052, H480053, H480054, H480055, H480107, H480133, H480293, H480346, H480347, H480472, H480652, H480920, H481467, H481510, H481639, H481724, H481807, H481815, H481816, H481912, H481913, H481914, H481915, H482194, H482195, H482289, H482793, H482807, H483204, H483407, H484367, H484635, H484636, H484637, H484638, H484781, H484864, H485100, H485125, H485244, H485346, H485466, H485729, H486858, H486859, H486860, H486861, H486946, H486947, H486948, H487190, H487212, H487414, H487580, H487581, H487623, H487640, H487641, H487642, H487700, and H487757.
Recalling Firm/
Manufacturer
Varian Medical Systems Oncology Systems
911 Hansen Way
Palo Alto, California 94304-1028
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
When using the multiple static segment option, the device may alter dose delivery.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action An Urgent Medical Device Correction Letter was distributed to all affected users, with a description of the problem and user corrective action steps on October 2, 2008. The Letter will also be distributed to the Varian Sales, Marketing, and Service organizations, informing them of the issue. The firm recommends that customers DO NOT USE the Multiple Static Segment (MSS) option in Varian Leaf Motion Calculator version 8.2.22. The firm also recommends setting the default delivery method for Varian Leaf Motion Calculator to Sliding Window. When using Eclipse 8.5, always follow the Safety Instructions found in chapter 2 of "Eclipse External Beam Planning Instruction for Use", P/N B501357R01A, March 2008. If customers believe a patient treatment has been affected by this issue, they should notify a Varian Service or Support person as soon as possible.
Quantity in Commerce 64 units
Distribution Worldwide Distribution --- including USA and countries of Switzerland and the Netherlands.
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 = VARIAN MEDICAL SYSTEMS, INC.
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