Events

Recall of Device Recall Varian Medical Systems OnBoard Imager, Versions 1.0.15 and 1.2.05

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems 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
    46920
  • Event Risk Class
    Class 2
  • Event Number
    Z-1442-2008
  • Event Initiated Date
    2008-01-03
  • Event Date Posted
    2008-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68505
  • 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
    Medical Linear Accelerator - Product Code IYE
  • Reason
    If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.
  • Action
    The firm has upgraded all user sites through normal course of service and installation activities. Notification letters were distributed starting January 03, 2008.

Device

Device Recall Varian Medical Systems OnBoard Imager, Versions 1.0.15 and 1.2.05
  • Model / Serial
    All serial numbers between H080002 to H080006, H080008 to H080014, H080016 to H080022, H080024 to H080050, H080052 to H080057, H080059 to H080066, H080068 to H080070, H080072 to H080075, H080077, H080078, H080080 to H080089, H080091, H080092, H080094 to H080105, H080107 to H080117, H080119 to H080134, H080136, H080137, H080139 to H080145, H080147 to H080158, H080160 to H080163, H080166, H080168 to H080200, H080202 to H080222, H080224 to H080228, H080230 to H080232, H080235, H080236, H080239, H080240, H080244, H080246 to H080248, H080251, H080254, H080256 to H080258, H080260 to H080263, H080265 to H080268, H080271 to H080282, H080286 to H080288, H080290 to H080292, H080294, H080296, H080301, H080303, H080304, H080306, H080307, H080309, H080311, H080312, H080314, H080318, H080320, H080321, H080324, H080325, H080328, H080329, H080335, H080348, H080351, H082000 to H082002, H082007, H082009 to H082012, H082020 to H082023, H082026, H082034, H082036, H082038, H082043, H082044, H082048, H082070, H082073, H082088, and H082204 .
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of GA, MI, NY, MN, TX, TN, CA, MD, KS, AL, KY, CT, WI, LA, NC, NJ, PA, IL, RI, FL, NE, AK, VA, WV, NV, MO, TN, OR, IN, MA, CT, AL, AZ, NH, ID, OH, SC, CO, CT, ND, WA, and UT, and countries of Sweden, Switzerland, Germany, Denmark, Japan, UK, France, Italy, Norway, Taiwan, New Zealand, Canada, Poland, Australia, Colombia, China, Spain, Belgium, Russian Federation, India, Iceland.
  • Product Description
    Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
  • Manufacturer
    Varian Medical Systems Oncology Systems

Manufacturer

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