Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling three Proteus 235 proton therapy systems in Florida due to potential energy range discrepancies in the first layer of irradiation plans.
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 high-risk medical device (proton therapy) where a technical defect could lead to incorrect treatment delivery, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Ion Beam Applications S.A. is recalling three units of the Proteus 235 Proton Therapy System, specifically the Pencil Beam Scanning version PTS-6.4.11.X. These medical devices are designed to produce and deliver proton beams for the treatment of patients with localized tumors and other conditions susceptible to radiation therapy. The affected units were distributed to the state of Florida.
The recall is issued because the range for the same energy could be different depending on whether the layer is the first layer of the irradiation plan or not. This discrepancy in the device's software or planning parameters may affect the precision of the proton beam delivery during treatment.
Facilities using these specific devices should contact Ion Beam Applications S.A. for instructions on how to address the issue. Patients who have received treatment on these specific units should consult their healthcare providers for further information regarding their treatment plans.
The recalled product
- Product
- Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions
- Manufacturer
- Ion Beam Applications S.A.
- Affected units
- 3
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 (2)
- PAT.003 (KR)
- PAT.006 (US)
Distribution
Distributed in 1 state:
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