Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling 14 Proteus 235 proton therapy systems because an accessory can be improperly inserted, allowing the device to operate incorrectly.
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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Ion Beam Applications S.A. is recalling 14 units of the Proteus 235 Proton Therapy System (brand names Proteus Plus and Proteus ONE). The recall involves a defect where an accessory, specifically a range shifter or ridge filter, can be improperly inserted into the snout 300x400 with only one rail engaged. Despite this improper insertion, the proton therapy system is capable of continuing to operate.
The affected devices are distributed in the United States to the states of Massachusetts, Florida, Virginia, Pennsylvania, Oklahoma, and Tennessee. The specific units involved are identified by the following codes: PAT.000 (US), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), and SAT.119 (US).
This recall is classified as Class II by the FDA. The source text does not report any specific injuries or illnesses associated with this defect. Healthcare facilities using these devices should contact the manufacturer for instructions on how to address the issue.
The recalled product
- Product
- Proteus 235, Uniform and Pencil Beam Scanning 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
- 14
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 (8)
- PAT.000 (US)
- PAT.003 (KR)
- PAT.006 (US)
- PAT.107 (EU)
- PAT.108 (US)
- PAT.109 (US)
- PAT.110 (US)
- SAT.119 (US).
Distribution
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