Z-1846-2014Class II

ProBeam Proton Therapy System (HGA and HFB)

Name: Z-1846-2014 ProBeam Proton Therapy System (HGA and HFB)
Creator: Varian Medical Systems Particle Therapy Gmbh
Published: 2014-05-09
License: https://open.fda.gov/license/

Varian Medical Systems Particle Therapy GmbH / initiated 2014-05-09 / Terminated

FDA source

VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH began a recall of ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and... on 2014-05-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1846-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-09
Posted: 2014-06-21
Terminated: 2014-11-12
Recalling firm: Varian Medical Systems Particle Therapy GmbH
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.
Product code: LHN System, Radiation Therapy, Charged-Particle, Medical
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.
FDA root cause: Under Investigation by 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].
Quantity in commerce: 1
Distribution: US Distribution in tthe state of CA
Product codes and lots: Codes: HFB0031, HGA0032, HGA0033, HGA0034, HFB0035.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1846-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1846-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-20

Product code LHN

K133191Class IIProbeam Proton Therapy SystemVarian Medical Systems / cleared 2014-01-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)