Ion Beam Applications Recalls Two Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling two Proteus 235 proton therapy systems in Florida because the device may restart irradiation from the beginning after a pause instead of recalculating the dose.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the potential for incorrect radiation dosing in a medical device is a significant hazard.
Plain-English summary
Ion Beam Applications S.A. is recalling two units of the Proteus 235 (also known as Proteus Plus) proton therapy system. These medical devices are 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 due to a software or operational issue where a Pencil Beam Scanning (PBS) irradiation may pause for various reasons. After such a pause, the system may restart the irradiation from the beginning instead of recalculating the treatment field based on the dose that has already been delivered. This could result in the patient receiving an incorrect dose of radiation.
The affected units are identified by serial numbers PAT.003 and PAT.006. The distribution pattern indicates these devices were located in Florida (FL). Ion Beam Applications S.A. is the recalling firm.
The recalled product
- Product
- Proton therapy system -Proteus 235 aka Proteus Plus. 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.
- Manufacturer
- Ion Beam Applications S.A.
- Affected units
- 2
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)
- Serial numbers: PAT.003
- PAT.006
Distribution
Distributed in 1 state:
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