Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1846-2014 — 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.

U.S. FDA — Device Enforcement · Germany · 2014-05-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1846-2014
Date of alert
2014-05-09
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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