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Recall Observatory FDA recall evidence

Device 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.

Z-1846-2014

May 09, 2014

Class II

Product summary

Firm
VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
Event
Event 68384
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1846-2014

Official wording

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.

Code information: Codes: HFB0031, HGA0032, HGA0033, HGA0034, HFB0035.

Distribution pattern: US Distribution in tthe state of CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.