Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam f

FDA device recall Z-2424-2018 · posted 2018-06-20 · Terminated

Recall details

Recalling firm

Ion Beam Applications S.A.

Reason for recall

Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.

Action taken

On May 18, 2018 IBA issued URGENT FIELD SAFETY NOTICES to their customers. Customers were advised to take the following actions: It is recommended to ensure that the correction vector confirmation message appears on the expected access point. When the correction vector is applied (if deemed necessary1), ensure that the Patient Positioning System GoTo the corrected position for treatment before starting irradiation: - verify on adaPTdeliver screen that the corrected target position is selected before engaging the movement. - verify on adaPTdeliver screen that the corrected target position appears on the screen after the movement. Moreover, as advised in the Proton Therapy System Clinical User Guide, it is recommended to verify the patient position after each correction vector application. A software update will be deployed on all affected sites by July 2018. Customers with questions may email: vigiliance@iba-group.com

Root cause

Software design

Status

Terminated

Product code

LHN

Quantity affected

3 units

Distribution

Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands

Date initiated

2018-05-16

Date posted

2018-06-20

Date terminated

2018-10-16

Location

Louvain La Neuve, Belgium

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