Reported Jun 20, 2018 · Terminated

Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients…

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

Proteus 235 The PTS 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 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: Code/Serial Numbers
PAT.000
PAT.003
PAT.006
PAT.107
PAT.108
PAT.109
PAT.110
PAT.111
PAT.112
PAT.113
PAT.114
PAT.115
SAT.116
SAT.117
SAT.119
SAT.120
SAT.122
SAT.123
SAT.126
Amount recalled: 19 units

The agency filed one notice per product. You are reading one of them; the other 2 are below.

IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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29 in total.