FDAFDA · Food and drugs·Recall number Z-1846-2014
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.
Published July 2, 2014 · Recall initiated: May 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
- Distributor
- US Distribution in tthe state of CA
- Lot
- Codes: HFB0031, HGA0032, HGA0033, HGA0034, HFB0035.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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