Recall Z-1846-2014 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
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.
| Date | Jun 21, 2014 (initiated May 9, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| 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. |
| Quantity | 1 |
| Distribution | US Distribution in tthe state of CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133191 | PROBEAM PROTON THERAPY SYSTEM Varian Medical Systems, Jan 10, 2014 |