Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling 37 Proteus 235 Proton Therapy Systems due to a risk of patient misalignment when using treatment plans with multiple isocenters.
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: The recall involves a risk of patient misalignment during radiation therapy, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ion Beam Applications S.A. is recalling 37 units of the Proteus 235 Proton Therapy System. This medical device is designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The recall is being conducted because there is a risk of misalignment of the patient when using treatment plans with multiple isocenters. The affected units were distributed nationally in the United States, China, Korea, and the European Union.
Healthcare facilities that have purchased or received these devices should contact Ion Beam Applications S.A. for further instructions on how to address the issue.
The recalled product
- Product
- Proteus 235, Proton Therapy System a medical device designed to produce and delivers 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
- Affected units
- 37
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 (20)
- PAT.000 (US)
- PAT.001 (CN)
- PAT.003 (KR)
- PAT.006 (US)
- PAT.107 (EU)
- PAT.108 (US)
- PAT.109 (US)
- PAT.110 (US)
- PAT.111 (EU)
- PAT.112 (US)
- PAT.113 (US)
- PAT.114 (EU)
- PAT.115 (EU)
- SAT.116 (US)
- SAT.117 (EU)
- SAT.119 (US)
- SAT.120 (EU)
- SAT.122 (EU)
- SAT.123 (US)
- SAT.126 (US)
Distribution
Distribution scope not specified by the agency.
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