Z-0544-2008

Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High...

Name: Z-0544-2008 Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High...
Creator: Varian Medical Systems Inc
Published: 2007-09-10
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2007-09-10 / Terminated / root cause: labeling and UDI

FDA source

Varian Medical Systems Inc began a recall of Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following... on 2007-09-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0544-2008
Status: Terminated
Initiated: 2007-09-10
Posted: 2008-02-14
Terminated: 2010-11-27
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
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 418 (total for Recalls Z-0544-0545-2008)
Distribution: Worldwide- Canada, Mexico, and the USA
Product codes and lots: 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

Product code IYE

K070094Class IITrilogy Radiotherapy Delivery System and Trilogy Tx Delivery SystemVarian Medical Systems, Inc. / cleared 2007-02-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)