Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems
Ion Beam Applications is recalling four Proteus 235 Proton Therapy Systems because a software defect prevents users with long names from resuming interrupted treatments.
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 high-risk medical device where a software defect prevents the completion of interrupted radiation treatments, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ion Beam Applications S.A. is recalling four units of the Proteus 235 Proton Therapy System, also known by the brand names Proteus Plus and Proteus ONE. 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 therapy. The affected units were distributed worldwide, including in the United States (specifically Florida and Virginia) and in Belgium and Spain.
The recall is due to a software issue where the system does not accept user names with more than ten characters. A user's signature is required to resume an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic Unit (DCEU). If the user's signature contains more than ten characters, they will be unable to complete the aborted treatment field. Additionally, at sites using Electronic Medical Records (EMR), the system may reject local partial archives if the Patient Positioning System (PPS) position has changed, forcing users to rely on the DCEU dose counter instead of full beam details.
The affected units are identified by the following serial numbers and manufacture dates: SAT.140 (US, May 2019), SBF.112 (EU, October 2019), SBF.113 (US, June 2019), and SBF.117 (EU, November 2019). Healthcare facilities with these devices should contact Ion Beam Applications S.A. for further instructions on resolving the software defect.
The recalled product
- Product
- Proteus 235 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 susceptible to treatment by radiation.
- Manufacturer
- Ion Beam Applications S.A.
- Affected units
- 4
Distribution
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