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U.S. Department of Health and Human Services

Class 2 Device Recall Varian

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  Class 2 Device Recall Varian see related information
Date Initiated by Firm September 10, 2007
Date Posted February 14, 2008
Recall Status1 Terminated 3 on November 27, 2010
Recall Number Z-0544-2008
Recall Event ID 45520
510(K)Number K070094  
Product Classification Linear Accelerator - Product Code IYE
Product Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options:
-- BrainLAB micro MLC,
-- 6MV SRS photon beam,
-- Fine Beam Isocenter Accuracy,
-- Stereotactic motion disable.
----Product is manufactured and distributed by Varian Medical Systems, Palo Alto, CA
Code Information The Serial Numbers: H271306; including: H140010, H140046, H140047, H140060, H140095, H140098, H140120, H140124, H140130, H140143, H140144, H140145, H140148, H140152, H140201, H140202, H140203, H140204, H140208, H140209, H140210, H140211, H140213, H140214, H140217, H140218, H140220, H140221, H140223, H140224, H140225, H140226, H140227, H140229, H140233, H140235, H140237, H140703, H140706, H140715, H140716, H140721, H140723, H140725, H140727, H140728, H140731, H140735, H140742,  H270144, H270357, H270412, H270423, H270518, H270608, H270615, H270618, H270680, H270707, H270750, H270792, H270811, H270845, H270862, H270885, H270890, H270893, H271013, H271023, H271031, H271049, H271112, H271113, H271118, H271122, H271154, H271169, H271224, H271275, H271333, H271341, H271345, H271358, H271365, H271413, H271444, H271602, H271673, H271790, H271852, H271879, H271890, H271893, H271906, H271940, H271962, H271964, H271977, H271999, H272023, H272061, H272105, H272108, H272148, H272153, H272184, H272203, H272230, H272241, H272242, H272273, H272319, H272320, H272360, H272375, H272380, H272437, H272452, H272494, H272804, H272822, H272854, H272856, H272892, H272929, H272931, H272982, H273001, H273007, H273019, H273042, H273086, H273120, H273123, H273127, H273132, H273136, H273137, H273146, H273157, H273165, H273180, H273189, H273190, H273197, H273209,  H290106, H290107, H290142, H290165, H290176, H290179 , H290186, H290201, H290203, H290205, H290206, H290213, H290215, H290236, H290244, H290254, H290259, H290326, H290358, H290404, H290503, H290504, H290508, H290512, H290517, H290519, H290520, H290535, H290548, H291002, H291005, H291008, H291012, H291014, H291017, H291018, H291023, H291024, H291025, H291033, H291036, H291037, H291043, H291046, H291047, H291050, H291053, H291056, H291059, H291062, H291064, H291069, H291070, H291071, H291073, H291082, H291083, H291084, H291086, H291087, H291091, H291094, H291095, H291096, H291099, H291108, H291109, H291112, H291113, H291117, H291119, H291121, H291127, H291128, H291129, H291130, H291133, H291135, H291140, H291141, H291144, H291150, H291158, H291163, H291164, H291165, H291166, H291167, H291168, H291169, H291170, H291171, H291172, H291174, H291178, H291179, H291181, H291182, H291185, H291193, H291196, H291200, H291203, H291204, H291205, H291206, H291208, H291209, H291211, H291214, H291216, H291217, H291218, H291220, H291223, H291224, H291231, H291237, H291238, H291241, H291247, H291248, H291250, H291251, H291254, H291255, H291256, H291264, H291265, H291269, H291270, H291272, H293303, H293311, H293313, H293319, H293330, H293331, H293335, H293342, H293344, H293346, H293348, H293355, H293356, H293360, H293367, H293385, H293394, H293395, H293397, H293398, H293400, H293401, H293404, H293405, H293406, H293410, H293414, H293416, H293417, H293418, H293423, H293425, H293426, H293437, H293438, H293439, H293441, H293447, H293449, H293451, H293452, H293456, H293457, H293458, H293466, H293470, H293475, H293476, H293477, H293478, H293479, H293480, H293481, H293483, H293484, H293488, H293490, H293502, H293505, H293509, H293515, H293516, H293517, H293518, H293525, H293531, H293537, H293541, H293543, H293544, H293546, H293557, H293558, H293560, H293561, H293562, H293565, H293572, H293581, H293583, H293593, H293596, H293598, H293599, H293614, H293627, H293630, H293635, and H293642 
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
911 Hansen Way
Palo Alto CA 94304
For Additional Information Contact
650-424-5731
Manufacturer Reason
for Recall		 Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.
FDA Determined
Cause 2		 Labeling design
Action On 9/10/07, the firm issued an Urgent Medical Device Correction letter to all its direct consignees, informing them of the device defect and providing instructions on the recall. Short term user instructions were provided and the firm will schedule follow-up visits to make the needed permanent device corrections at each device site.
Quantity in Commerce 418 (total for Recalls Z-0544-0545-2008)
Distribution Worldwide- Canada, Mexico, and the USA
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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