Class II

Medical Device Recall: IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

Ion Beam Applications S.A. · March 4, 2024

Reason for Recall

There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

Distribution

US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.

States Affected

NATIONWIDE

Quantity Affected

8 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1603-2024

Status: ongoing

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