Recall Z-1846-2014— VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH

Name: FDA recall Z-1846-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-09

Class II · Terminated

Class II FDA medical device recall by VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH, initiated 2014-05-09, terminated 2014-11-12. It names one FDA 510(k) clearance: K133191. Product: 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..

Recalling firm: VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
Classification: Class II
Status: Terminated
Initiated: 2014-05-09
Terminated: 2014-11-12
Firm location: BERGISCH GLADBACH, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K133191 — PROBEAM PROTON THERAPY SYSTEMVarian Medical Systems·cleared 2014-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.