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Terminated

Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer

FDA Recall Z-1013-2015 · Posted 2015-01-26

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-01-02
Date Terminated2015-09-10
Product Quantity3

Reason for Recall

Combination of CTVision with syngo RT Therapist / syngo RT Oncologist 4.3.SP1 automatic registration in Adaptive Targeting might result in wrong offset calculations. Applying this offset can lead to patient mistreatment. Cone Beam imaging is not affected by this problem.

Firm Action

A customer advisory notice, dated January 2, 2015, was sent to end users which identified the product, problem, and action to be taken. It was recommended that customers use only manual registration with the 6 degrees of freedom option disabled, which provides the correct offset values. A software update will be deployed once a solution is available.

Root Cause

Software Design Change

Distribution Pattern

UT, WI, NY

Official Source

View FDA Recall →

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

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