Events

Recall of Device Recall ProBeat Proton Therapy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH.

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
    68384
  • Event Risk Class
    Class 2
  • Event Number
    Z-1846-2014
  • Event Initiated Date
    2014-05-09
  • Event Date Posted
    2014-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127498
  • 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
    System, radiation therapy, charged-particle, medical - Product Code LHN
  • Reason
    Anomaly with the probeam system where under certain conditions, the treatment control and monitoring application could fail to send treatment history records to the aria database.
  • Action
    Varian sen an Urgent Device Medical Correction/Urgennt Field Safety Notice letter dated May 9, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions cotact Varian Service Support. at debg-PT-service-support@varian.com.

Device

Device Recall ProBeat Proton Therapy System
  • Model / Serial
    Codes: HFB0031, HGA0032, HGA0033, HGA0034, HFB0035.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in tthe state of CA
  • Product Description
    ProBeam Proton Therapy System (HGA and HFB) || Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
  • Manufacturer
    VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH

Manufacturer

VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
  • Manufacturer Address
    VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH, FRIEDRICH-EBERT-STR. 1, BERGISCH GLADBACH Germany
  • Manufacturer Parent Company (2017)
    Varian Medical Systems Inc
  • Source
    USFDA