medical Class II Updated 2021-09-15

Ion Beam Applications S.A. recalls Proteus 235- designed to produce and deliver a proton beam f

Recalled Product

Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation


Hazard / Issue

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US), SBF.115 (UK), SBF.117 (EU).
View official government recall

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