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Terminated

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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-2684-2017 · Posted None

Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2016-12-13
Date Terminated2019-04-12
Product Quantity6 worldwide and 5 in the U.S.

Reason for Recall

Software issue

Firm Action

An Urgent Field Safety Notice was mailed to affected customers to inform them of the issue. The notice indicated possible software failure, the associated risks and actions users should implement to correct the issue. IBA plans to follow-up with a software update which will be deployed on impacted sites to correct this issue.

Root Cause

Software design

Distribution Pattern

Distributed to FL, VA, IL, NJ, WA and South Korea

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. · 2016-08-09

Official Source

View FDA Recall →

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

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