Reported Jul 25, 2018 · Terminated
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed…
Ion Beam Applications S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ion Beam Applications S.A. · Chemin Du Cyclotron 3 · Louvain-la-neuve · N/A
Is this the product you have?
Proteus 235Universal Nozzle with snout 300x400PBS dedicated
- nozzle with snout XL Product UsageDevice is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck
- Lot codes and dates
PAT.003PAT.006PAT.107PAT.108PAT.109PAT.110PAT.111PAT.113PAT.114PAT.115PAT.116PAT.120PAT.126and PAT.132
- Amount recalled
- 14
Where it was sold
Why it was recalled
Gantry rotation or proton irradiation can be allowed even if apertures or accessories are not correctly positioned in snout 300x400 or snout XL. This can lead to risk of crushing for patient and/or user, and risk of mistreatment for the patient.
This product could cause temporary or reversible health problems — stop using it.
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