Device Recall TrueBeam Radiotherapy Delivery System

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***

Radiology Devices

2

No

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.

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.