Reported Jul 2, 2014 · Terminated

ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision…

Varian Medical Systems Particle Therapy GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH · FRIEDRICH-EBERT-STR. 1 · BERGISCH GLADBACH, N/A · N/A

Is this the product you have?

  • ProBeam Proton Therapy
  • System (HGA and HFB) Product UsageProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated
Lot codes and dates
  • Codes
    • HFB0031
    • HGA0032
    • HGA0033
    • HGA0034
    • HFB0035
Amount recalled
1

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 12, 2014 · Data as of Sep 19, 6:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.