Reported Aug 4, 2021 · Ongoing
Proteus 235-Proton Therapy System
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 · N/A
Is this the product you have?
- Proteus 235-Proton Therapy System
- Lot codes and dates
- Serial Numbers
PAT.107 (EU)PAT.108 (US)PAT.109 (US)PAT.115 (EU)SAT.117 (EU)SAT.118 (RU)SAT.119 (US)SAT.120 (EU)SAT.122 (EU)SAT.125 (IN)SAT.126 (US)SAT.132 (EU)SAT.133 (US)
- Serial Numbers
- Amount recalled
- 5 US; 8 OUS
Where it was sold
Why it was recalled
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
This product could cause temporary or reversible health problems — stop using it.
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