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Terminated

Proteus ONE and Proteus Plus

FDA Recall Z-2139-2018 · Posted None

Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2016-09-16
Date Terminated2019-02-08

Reason for Recall

IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.

Firm Action

IBA mailed an Urgent Field Safety Notice to affected customers on 09/16/2016 to notify them of the risks associated with the use of this device to prevent serious injury/death. Customers were asked not to make any unauthorized modification to the IBA System or IBA accessories unless approved in writing or in advance by IBA. IBA will be updating their manuals to include these warnings.

Root Cause

Finished device change control

Distribution Pattern

Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.

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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