FDA Medical Device Recalls (openFDA)
VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH: 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.
- Recall number
- Z-1846-2014
- 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.
- Status
- Terminated
- Initiated
- 2014-05-09
- Posted
- 2014-06-21
- Terminated
- 2014-11-12
- 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.
- 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 debg-PT-service-support@varian.com.
- Quantity
- 1
- Distribution
- US Distribution in tthe state of CA
- Lot, serial or model codes
- Codes: HFB0031, HGA0032, HGA0033, HGA0034, HFB0035.
- 510(k) numbers
- ["K133191"]
- PMA numbers
- not on file
- Product code
- LHN
- Firm FEI
- 3008889206
- Firm city
- BERGISCH GLADBACH
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28