Events

Recall of Device Recall Oncor AvantGarde Medical Linear Accelerator

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

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
    46940
  • Event Risk Class
    Class 2
  • Event Number
    Z-1399-2008
  • Event Initiated Date
    2008-01-11
  • Event Date Posted
    2008-04-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69045
  • 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
    Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
  • Action
    This is a mandatory software upgrade for consignees. The firm's representatives have contacted consignees via Urgent Device Notification letters dated February 14, 2008, notifying them of the new update and making arrangements to install it.

Device

Device Recall Oncor AvantGarde Medical Linear Accelerator
  • Model / Serial
    Serial Numbers: 3576 3938 70-4283 3738 3817 3987 3988 4095 70-4368 4016 3904 3926 4079 4082 70-4077 70-4113 70-4197 3905 3934 3852 3737 3758 3856 3891 3929 3937 70-4163 3895 3896 4049 70-4201 70-4184 5038 70-4213 70-4223 5012 70-4311 3932 3739 3806 3884 3912 3941 70-4297 70-4314 and 70-4217
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV, WI, and WY and countries of Angola, Australia, Austria,Belgium,Brazil,Canada,Chile,Colombia,Costa Rica, Croatia,Cyprus,The Czech Republic,Denmark,DPR of Korea,El Salvador,France,Germany,Greece,Hungary,India,Iran,Ireland,Italy,Japan,Jordan,Malaysia,Mexico, The Netherlands,New Zealand,Norway,P.R. China,Pakistan,Peru,Philippines,Poland,Portugal,Republic of Korea,Romania,Russian Fed.Saudi Arabia,Singapore,Slovakia,South Africa,Spain,Sweden,Taiwan,Thailand,Trinidad,Tobago,Turkey, U.A.E.,Ukraine, The United Kingdom, and Venezuela
  • Product Description
    Oncor Avante-Garde Medical Linear Accelerator, Material Number: 5857920, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA