Proton Therapy System software startup allows test processes to contaminate clinical environment
The Proteus 235 proton therapy system can start clinical processes while test processes are still running, potentially using test components in clinical treatments without user notification. This could impact patient treatment if versions differ.
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 classification with no reported hospitalizations, injuries, or illnesses. The recall addresses a software configuration risk that could impact patient treatments, but the hazard is theoretical without documented harm. Per the rubric, this risk-of-harm without reported injury meets the High (3) criterion.
Plain-English summary
The Proteus 235 proton therapy system (PTS-8 versions before PTS-8.7.2), manufactured by Ion Beam Applications S.A., is affected by a software configuration issue where clinical processes can be initiated while test environment processes continue running.
The system does not prevent clinical startup when test processes remain active. If the versions of test and clinical processes differ, the clinical user will not be notified that test components are being used, potentially impacting patient treatment.
The recall affects five devices distributed in Virginia, Oklahoma, New Jersey, and Tennessee in the United States, as well as facilities in the Czech Republic.
Healthcare facilities with affected devices should contact Ion Beam Applications S.A. to obtain and apply the software update to PTS-8.7.2 or later.
The recalled product
- Product
- Proteus 235; Version: PTS-8 versions before PTS-8.7.2
- Manufacturer
- Ion Beam Applications S.A.
- Hazard
- software-configuration-error
- patient-treatment-impact
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)
- PAT.108 (US)
- PAT.110 (US)
- PAT.113 (US)
- PAT.114 (EU)
- SAT.119 (US).
Distribution
Distributed in 5 states:
- IN
- NJ
- OK
- TN
- VA
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