Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems Due to Software Issue
Ion Beam Applications S.A. is voluntarily recalling six Proteus 235 Proton Therapy Systems worldwide due to a software issue. Five of these units are located in the United States.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The rubric assigns a score of 3 to risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ion Beam Applications S.A. is voluntarily recalling the Proteus 235 Proton Therapy System. This medical device is designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to radiation therapy. The recall was initiated due to a software issue.
A total of six units are affected worldwide, with five units located in the United States. The affected units were distributed to facilities in Florida, Virginia, Illinois, New Jersey, Washington, and South Korea. The specific serial numbers for the recalled units are PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, and PAT.003.
The recall was initiated by the firm on December 13, 2016, and was classified as Class II by the FDA. The recall status is currently terminated as of April 12, 2019. Facilities with these devices were notified via letter.
The recalled product
- Product
- Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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. The PTS…
- Manufacturer
- Ion Beam Applications S.A.
- Hazard
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 (6)
- Serial Numbers: PAT.006
- PAT.108
- PAT.112
- PAT.113
- SAT.116
- PAT.003
Distribution
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