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Terminated

Proteus 235, graphite block 8

FDA Recall Z-0930-2018 · Posted None

Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2017-10-17
Date Terminated2019-03-29
Product Quantity3

Reason for Recall

IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader

Firm Action

On July 17, 2017 An Urgent Field Safety Notice was issued to customers with the following user action: In case a patient treatment plan requires the use of the block 8, it is recommended to perform a full range verification during the patient treatment plan QA check. After the replacement of the graphite block 8, it is recommended to verify there is no effect on the Bragg peak.

Root Cause

Component design/selection

Distribution Pattern

WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101508MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235Ion Beam Applications S.A. · 2010-08-06

Official Source

View FDA Recall →

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

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