Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling 19 Proteus 235 proton therapy systems to provide safety information to maintenance technicians regarding ion source replacement.
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 3/5 (High).
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 high-risk medical device where a risk of harm to maintenance technicians is identified, but no injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Ion Beam Applications S.A. is recalling 19 units of the Proteus 235 medical device. The Proteus 235 is designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to radiation treatment.
The recall is being conducted to provide information through a Safety Notice intended to reduce risk for maintenance technicians during the process of replacing the ion source. The source text does not specify the exact nature of the risk or the specific technical defect, only that the notice is meant to mitigate hazards for technicians.
The affected units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed of the recall. The specific serial numbers for the affected units are PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, and SAT.126.
The recalled product
- Product
- Proteus 235 The PTS is a medical device 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 PTS may include a fixed small beam treatment room dedicated to the…
- Manufacturer
- Ion Beam Applications S.A.
- Hazard
- Affected units
- 19
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 (19)
- Code/Serial Numbers: PAT.000
- PAT.003
- PAT.006
- PAT.107
- PAT.108
- PAT.109
- PAT.110
- PAT.111
- PAT.112
- PAT.113
- PAT.114
- PAT.115
- SAT.116
- SAT.117
- SAT.119
- SAT.120
- SAT.122
- SAT.123
- SAT.126.
Distribution
Distribution scope not specified by the agency.
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