ProBeam Proton Therapy System Recalled for Treatment History Data Loss
Varian Medical Systems is recalling ProBeam Proton Therapy Systems because the Treatment Control and Monitoring application may fail to send treatment history records to the ARIA database.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a data transmission failure (documentation issue) rather than a direct physical injury or high-risk pathogen, fitting the 'Moderate' criteria for minor labeling/documentation errors or low-risk issues.
Plain-English summary
Varian Medical Systems Particle Therapy GmbH is recalling the ProBeam Proton Therapy System (HGA and HFB) in the United States. The recall is limited to units in California with serial codes HFB0031, HGA0032, HGA0033, HGA0034, and HFB0035.
The recall is due to an anomaly where the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database under certain conditions. This issue affects the documentation of treatment history rather than the delivery of radiation itself.
Healthcare facilities using these specific units should contact Varian Medical Systems for further instructions on how to address the data transmission issue.
The recalled product
- 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.
- Manufacturer
- VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Codes: HFB0031
- HGA0032
- HGA0033
- HGA0034
- HFB0035.
Distribution
Distributed in 1 state:
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