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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.

FDA Recall Z-1846-2014 · Posted 2014-06-21

Recalling FirmVARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
Recall StatusTerminated
Product CodeLHN
Date Initiated2014-05-09
Date Terminated2014-11-12
Product Quantity1

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.

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 [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

US Distribution in tthe state of CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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