ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision r
FDA device recall Z-1846-2014 · posted 2014-06-21 · Terminated
Recall details
- Recalling firm
- VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
- Reason for recall
- 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 taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 1
- Distribution
- US Distribution in tthe state of CA
- Date initiated
- 2014-05-09
- Date posted
- 2014-06-21
- Date terminated
- 2014-11-12
- Location
- BERGISCH GLADBACH, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROBEAM PROTON THERAPY SYSTEM (K133191) | Varian Medical Systems | 2014-01-10 |