Varian Medical Systems Inc: 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

Recall number

Z-0544-2008

Recalling firm

Varian Medical Systems Inc

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

Status

Terminated

Initiated

2007-09-10

Posted

2008-02-14

Terminated

2010-11-27

Reason

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.

Root cause

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

418 (total for Recalls Z-0544-0545-2008)

Distribution

Worldwide- Canada, Mexico, and the USA

Lot, serial or model codes

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

510(k) numbers

["K070094"]

PMA numbers

not on file

Product code

IYE

Firm FEI

2916710

Firm city

Palo Alto

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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