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Terminated

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.

FDA Recall Z-2173-2018 · Posted None

Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2016-08-07
Date Terminated2020-03-25
Product Quantity19 units

Reason for Recall

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

Firm Action

IBA mailed out a Field Safety Notice on August 2, 2016, to affected customers where this maintenance is not performed by IBA technicians to inform them of the issue. For further questions please call (215) 972-7985.

Root Cause

Employee error

Distribution Pattern

Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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