Proton Therapy System Delivers Incorrect Radiation Dose in First Layer
The Proteus235 Proton Therapy System may deliver radiation to initial treatment fields with incorrect scanning magnet settings. The radiation field may be smaller than expected and may deliver higher dose than prescribed.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a dose-delivery malfunction that can result in patient radiation overdose. The source does not report any illnesses or injuries. Per the severity rubric, this qualifies as High (3) because it is a risk-of-harm product without reported injury.
Plain-English summary
The FDA is recalling four units of the Proteus235 Proton Therapy System, manufactured by Ion Beam Applications S.A. This medical device is designed to produce and deliver proton beams for treating patients with localized tumors and other radiation-responsive conditions.
The first layer of uniform scanning treatment fields may be irradiated with incorrect scanning magnet setpoints. When this occurs, the radiation field size may be smaller than expected, resulting in the affected area receiving a higher radiation dose than prescribed.
Four units are affected: three in the United States (Illinois, Virginia, and Washington) and one in Germany. Patients and healthcare providers with these systems should be aware of this malfunction and contact Ion Beam Applications S.A. for information on corrective measures.
The recalled product
- Product
- Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
- Manufacturer
- Ion Beam Applications S.A.
- Hazard
- radiation-overdose
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 (3)
- UDI-DI: (01)05404013801138 Serial Numbers: PAT108 (US)
- PAT112 (US)
- SAT116 (US). PAT107 (EU).
Distribution
Distributed nationwide across the United States.
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