medical Class II Updated 2018-07-18

Ion Beam Applications S.A. recalls Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product

Recalled Product

Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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.


Hazard / Issue

Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)
View official government recall

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