FDAClass IIJuly 2, 2014

ProBeam Proton Therapy System recall

ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions…

Why was ProBeam Proton Therapy System recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions…
Recalling firm
VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
Quantity
1
Distribution
US Distribution in tthe state of CA
Recall date
July 2, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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