Events

Recall of Device Recall TrueBeam Radiotherapy Delivery System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems, Inc. Oncology Systems.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61196
  • Event Risk Class
    Class 2
  • Event Number
    Z-1175-2012
  • Event Initiated Date
    2012-01-30
  • Event Date Posted
    2012-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107546
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accelerator, linear, medical - Product Code IYE
  • 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.
  • 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).

Device

Device Recall TrueBeam Radiotherapy Delivery System
  • Model / Serial
    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***
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Varian Medical Systems, Inc. Oncology Systems

Manufacturer

Varian Medical Systems, Inc. Oncology Systems
  • Manufacturer Address
    Varian Medical Systems, Inc. Oncology Systems, 911 Hansen Way, Palo Alto CA 94304-1028
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA