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
HFB0031HGA0032HGA0033HGA0034HFB0035
- Codes
- 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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