Z-1846-2014 Class II Terminated
FDA device recall Z-1846-2014 was initiated by VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH on May 9, 2014 and is designated Class II. 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. The recall status is terminated (terminated November 12, 2014). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2014
- Initiation Date
- May 9, 2014
- Termination Date
- November 12, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product 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 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.
Distribution Pattern
US Distribution in tthe state of CA
Code Information
Codes: HFB0031, HGA0032, HGA0033, HGA0034, HFB0035.