FDA Recall
Terminated
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.
Recall: Z-1846-2014
·
Initiated May 9, 2014
Recall
- Recall Number
- Z-1846-2014
- Event Number
- 68384
- Firm
- VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH FRIEDRICH-EBERT-STR. 1 BERGISCH GLADBACH Germany
- FEI Number
- 3008889206
- Product Code
- LHN
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- May 9, 2014
- Posted
- June 21, 2014
- Terminated
- November 12, 2014
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.
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 [email protected].
Distribution
US Distribution in tthe state of CA
Quantity
1