Events

Recall of Device Recall Eclipse TPS

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
    46902
  • Event Risk Class
    Class 2
  • Event Number
    Z-1612-2008
  • Event Initiated Date
    2008-02-13
  • Event Date Posted
    2008-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68450
  • 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
    Radiation therapy treatment planning system - Product Code MUJ
  • Reason
    A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.

Device

Device Recall Eclipse TPS
  • Model / Serial
    Serial numbers all starting with H48 (model number): 6509, 6974, 6616, 6688, 6806, 6568, 6530, 6839, 6740, 7178, 6700, 6694, 6505, 6924, 6979, 6715, 6556, 6757, 6820, 6545, 6564, 7027, 6783, 6553, 6760, 6904, 6907, 7037, 6639, 7088, 6702, 6659, 6940, 6802, 6856, 6944, 6841, 6870, 6874, 6928, 6913, 6614, 7009, 6951, 6493, 6758, 7030, 6453, 6704, 6555, 6691, 6914, 6739, 6846, 6685, 6473, 7015, 6875, 6566, 6599, 6818, 7020, 6799, 6804, 6699, 7075, 6901, 6827, 6833, 6681, 6724, 6499, 6698, 6722, 7018, 6782, 6893, 6522, 6937, 6708, 6560, 6977, 6978, 6803, 6961, 6503, 6814, 7029, 6707, 6686
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed throughout the USA (in LA, IN, GA, MD, IL, AR, CA, MA, FL, AZ, SC, MO, CO, AL, OK, WA, MI, IN, NY, TX, MS, NE, TN, VA, WI, OR, DC, and NC) and internationally (Japan, Columbia, Canada, India, Czech Republic, Turkey, Germany, Portugal, Venezuela, Australia, South Korea).
  • Product Description
    Eclipse Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48
  • 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