Proton Therapy System May Continue Irradiation When Accelerator Control Parameters Out of Tolerance
Ion Beam Applications' IBA Proton Therapy System PROTEUS 235 may continue delivering radiation when critical accelerator control parameters are outside defined tolerances. Affected users should contact the manufacturer regarding firmware updates.
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: This is an FDA Class II recall for a therapeutic medical device where the malfunction poses a risk of incorrect radiation dosing. No illnesses, injuries, or deaths have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
The IBA Proton Therapy System PROTEUS 235, manufactured by Ion Beam Applications S.A., is used to deliver targeted proton beams for treating localized tumors and other radiation-susceptible conditions. Two units with serial numbers SAT136 and SAT140 have been identified as affected.
The recalled systems may not automatically interrupt irradiation when certain critical parameters of the C230 Accelerator Control Unit fall outside defined tolerances. This malfunction could result in patients receiving unintended radiation doses during treatment.
Affected systems have been distributed worldwide, including in Virginia and India. Health care facilities using these systems should contact Ion Beam Applications S.A. to obtain necessary firmware updates or guidance. No illnesses or injuries have been reported in connection with this issue at the time of the recall notice.
The recalled product
- Product
- IBA Proton Therapy System - PROTEUS 235 - Designed 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-malfunction
- improper-dosing
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 (2)
- SAT140 PTS-11 versions from PTS-11.1 and PTS-12 versions
- with C230 accelerator
Distribution
Distributed nationwide across the United States.
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