Ion Beam Applications Recalls Proteus 235 Medical Devices
Ion Beam Applications S.A. is recalling 18 Proteus 235 systems due to potential dark current issues in Pencil Beam Scanning mode.
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 medical device with a potential hazard (dark current) that could affect treatment, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ion Beam Applications S.A. is recalling 18 Proteus 235 systems, 10 of which are located in the United States. The devices are distributed worldwide, including in Germany, South Korea, France, Czech Republic, Italy, Poland, and Sweden. In the US, the systems are distributed to Massachusetts, Florida, Virginia, Pennsylvania, Illinois, New Jersey, Washington, Tennessee, Louisiana, and Texas.
The recall was initiated because testing revealed that there could be a clinically non-negligible amount of dark current in the Pencil Beam Scanning (PBS) treatment mode when the system is not irradiating between layers. Dark current is a well-known physics effect observed in cyclotrons.
Healthcare facilities and users of the affected serial numbers should contact Ion Beam Applications S.A. for further instructions regarding the recall.
The recalled product
- Product
- Proteus 235
- Manufacturer
- Ion Beam Applications S.A.
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 (18)
- Serial Numbers: PAT.000
- PAT.003
- PAT.006
- PAT.107
- PAT.108
- PAT.109
- PAT.111
- PAT.112
- PAT.113
- PAT.114
- SAT.115
- SAT.116
- SAT.117
- SAT.119
- SAT.120
- SAT.122
- SAT.123
- SAT.126
Distribution
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