Events

Recall of Device Recall LINAC aka FastPlan Treatment Planning Sysytem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian Medical Systems 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
    37803
  • Event Risk Class
    Class 2
  • Event Number
    Z-0978-2007
  • Event Initiated Date
    2007-03-09
  • Event Date Posted
    2007-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51587
  • 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 scalpel treatment planning system - Product Code IYE
  • Reason
    A software anomaly in a medical device used for patient treatment could result in accidental or unintended exposure radiation exposure. the tilt rotation compensation algorithm does not adequately compensate for the tilt rotation.
  • Action
    The recalling firm notified medical device end users by letter dated 03/09/07 and advised of the software anomaly and provided details for user corrective action pending software upgrade by the manufacturer.

Device

Device Recall LINAC aka FastPlan Treatment Planning Sysytem
  • Model / Serial
    S/Ns: HZ30001 HZ30020 HZ30021 HZ30033 HZ30054 HZ30061 HZ30108 HZ30139 HZ30144 HZ30167 HZ30171 HZ30178 HZ30207 HZ30208 HZ30224 HZ30230 HZ30251 HZ30265 HZ30280 HZ30283 HZ30293 HZ30294 HZ30299 HZ30312 HZ30330 HZ30342 HZ30349 HZ30368 HZ30398 HZ30403 HZ30404 HZ30407 HZ30422 HZ30426 HZ30460 HZ30461 HZ30462 HZ30485 HZ30495 HZ30507 HZ30508 HZ30509 HZ30511 HZ30513 HZ30520 HZ30531 HZ30537 HZ30540 HZ30556 HZ30557 HZ30571 HZ30572 HZ30573 HZ30574 HZ30588 HZ30604 HZ30612 HZ30617 HZ30620 HZ30640 HZ30646 HZ30649 HZ30656 HZ30670 HZ30674 HZ30675 HZ30681 HZ30684 HZ30698 HZ30703 HZ30727 HZ30731 HZ30740 HZ35070 HZ39020 HZ39066 HZ39071 HZ39165 HZ39997
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The medical devices were distributed to medical centers nationwide and worldwide.
  • Product Description
    LINAC Scapel Treatment Planning System, incorporating FastPlan software versions 4.0, 5.0, 5.0.1, 5.1, 5.1.1.
  • Manufacturer
    Varian Medical Systems Inc

Manufacturer

Varian Medical Systems Inc
  • Manufacturer Address
    Varian Medical Systems Inc, 911 Hansen Way, Palo Alto CA 94304-1038
  • Source
    USFDA