Events

Recall of Device Recall HighDefinition 120 MultiLeaf Collimator

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
    46852
  • Event Risk Class
    Class 2
  • Event Number
    Z-1459-2008
  • Event Initiated Date
    2008-01-30
  • Event Date Posted
    2008-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68342
  • 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 charged-particle radiation therapy system - Product Code IYE
  • Reason
    Dose calculation error: software anomaly may result in failure of a mlc leaf to reach planned position, potentially resulting in misadministration of dose to a patient.
  • Action
    Consignees were notified by a Medical Device Notification letter sent on 01/29/2008. The letter advised users to cease use of the device until a corrected version of the software is available. A representative will contact users to upgrade the application once the revised software has been validated and released for distribution.

Device

Device Recall HighDefinition 120 MultiLeaf Collimator
  • Model / Serial
    Serial Number 1009.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of NC, FL and CA.
  • Product Description
    High-Definition 120 MultiLeaf Collimator, Medical charged-particle radiation therapy system; Software Version 7.0; Product Code: H56; Accessory to Medical Linear Accelerator.
  • 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