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Terminated

ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

FDA Recall Z-2812-2015 · Posted 2015-09-24

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-08-05
Date Terminated2016-09-01
Product Quantity26

Reason for Recall

A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients.

Firm Action

Siemens sent Notification letters to affected customers. The letter identified the affected product, problem and actions to be taken. The letter advise customers that the software fix was rolled out to address multiple safety issues.

Root Cause

Software design (manufacturing process)

Distribution Pattern

Worldwide Distribution and US Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103606ARTISTE SOLUTION WITH SYS_VB50 UPDATESiemens Medical Solutions USA, Inc. · 2011-04-15K090683SYNGO RT THERAPIST CONNECTSiemens Medical Solutions USA, Inc. · 2009-05-08K060226ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc. · 2006-03-15K031764ONCOR AVANT-GARDE WITH COHERENCE WORKSPACESSiemens Medical Solutions USA, Inc. · 2003-09-05K993425PRIMUSSiemens Medical Solutions USA, Inc. · 1999-11-26

Official Source

View FDA Recall →

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

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