Ion Beam Applications Recalls Proteus Proton Beam Therapy Systems
Ion Beam Applications is recalling five Proteus proton beam therapy systems because a software error may cause under-irradiation or additional X-ray exposure.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that can lead to under-irradiation of tumors or additional radiation exposure, meeting the criteria for a Severe rating.
Plain-English summary
Ion Beam Applications S.A. is recalling five Proteus 235, ProteusPLUS, or Proteus ONE proton beam therapy systems. These devices are used to produce and deliver proton beams for the treatment of patients with localized tumors and other conditions susceptible to radiation treatment.
The recall is due to a software issue where, when switching from Pencil Beam Scanning to Uniform Scanning treatment mode, the tuning setpoints of the scanning magnets are not always taken into account. This mismatch leads to an error message. If a user resumes treatment without analyzing the error, it may lead to under-irradiation. If a user reboots the Scanning Magnets Power Supply Electronic Unit, it may delay treatment and require patient re-alignment, resulting in an additional X-ray dose.
The affected units are located in four US states (VA, IL, NJ, and WA) and one location in Germany. Affected software versions are PTS-7.X.X and PTS-8.X.X. Specific serial numbers include PAT.107 (EU) and PAT.108, PAT.112, PAT.113, and PAT.116 (US).
The recalled product
- Product
- Proteus 235, ProteusPLUS or Proteus ONE produces 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.
- Affected units
- 5
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)
- Affected version: PTS-7.X.X and PTS-8.X.X Serial numbers PAT.107 (EU)
- PAT.108
- PAT.112
- PAT.113
- PAT.116 (US)
Distribution
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