Varian Medical Systems, Inc. Oncology Systems: TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Recall number

Z-1175-2012

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Product

TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; Varian Medical Systems, Palo, Alto, CA 94304. TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

Status

Terminated

Initiated

2012-01-30

Posted

2012-03-06

Terminated

2014-04-16

Reason

An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during planning.

Root cause

Device Design

Action

Urgent Medical Device Correction/Urgent Field Safety Notices were sent on January 30, 2012 by certified mail to US and Canadian consignees. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** Varian Sales, Marketing and Service Organizations also were informed via letter the same day. The Field Safety Notice with customer distribution list was e-mailed to Varian International Customer Support Managers for translation (if necessary) to be sent to affected sites with return proof of notification to be sent to Varian. The notice informed users of the recommended actions. Questions were directed to the Varian Help Desk 1-888-827-4265 (US and Canada).

Quantity

182 units ***12-12-12 AMENDED TO: 200 units***

Distribution

Nationwide Distribution (USA) and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Netherlands, New Zealand, Norway, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, Turkey and the United Kingdom.

Lot, serial or model codes

Model H19: Code numbers:  H191182,H191035,H191150,H191100,H191103,H191040,H191072,H191065, H191089,H191116,H191068,H191160,H191141,H191113,H191027,H191145, H191026,H191093,H191054,H191189,H191129,H191090,H191197,H191022,H191063,H191010,H191162,H191078,H191098,H191142,H191066,H191005,H191018,H191076,H191188,H191048,H191137,H191064,H191153,H191044,H191151,H191046,H191136,H191067,H191031,H191077,H191158,H191028,H191156,H191088,H191132,H191009,H191069,H191085,H191186,H191101,H191094,H191039,H191124,H191073,H191183,H191008,H191133,H191016,H191003,H191071,H191175,H191152,H191168,H191099,H191166,H191029,H191036,H191155,H191092,H191034,H191043,H191045,H191074,H191170,H191130,H191055,H191147,H191178,H191114,H191107,H191164,H191047,H191015,H191091,H191019,H191038,H191163,H191203,H191110,H191061, H191049,H191179,H191096,H191079,H191106,H191017,H191154,H191006,H191024,H191108,H191149,H191052,H191199,H191023,H191117,H191033,H191104,H191131,H191011,H191118,H191087,H191109,H191053,H191187,H191126,H191191,H191042,H191080,H191161,H191105,H191012,H191025, H191115,H191111,H191140,H191020,H191013,H191169,H191127,H191086,H191144,H191095,H191125,H191002,H191112,H191021,H191138,H191014,H191135,H191139,H191097,H191032,H191102,H191119,H191128,H191060,H191001,H191198,H191057,H191122,H191146,H191157,H191143,H191083,H191180,H191121,H191181,H191123,H191081,H191165,H191176,H191056,H191120,H191082,H191041,H191070,H191134,H191148,H191030,H191058,H191007,H191177,H191051,H191172,H191059 and H191037,  *** 12-12-12, AMENDED INFO ***:  H191167, H191171, H191184, H191185, H191192, H191194, H191202, H191205, H191207, H191208, H191211, H191214, H191217, H191219, H191220, H191222, H191223, H191224***

510(k) numbers

["K111106"]

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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