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Terminated

LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. Product Usage: The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

FDA Recall Z-1059-2015 · Posted 2015-02-05

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-12-19
Date Terminated2017-01-26
Product Quantity310

Reason for Recall

A hardware update to replace the old PCB Assembly, Head Driver-G41 with PCB with overcurrent protection as a result of reports of the electric board inside the gantry showing signs of overheating, including thermal damage and smoke emission.

Firm Action

Siemens sent a Customer Advisory Notice Letter TH016/14/S, dated December 19, 2014, to end users that identified the product, problem, and actions to be taken. End users were advised to read the Field Safety Notice and include it with the User's Manual until the hardware update is completed.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - US Nationwide including Canada and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072485ARTISTE MV SASiemens Medical Solutions USA, Inc. · 2007-12-27K060226ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc. · 2006-03-15K031764ONCOR AVANT-GARDE WITH COHERENCE WORKSPACESSiemens Medical Solutions USA, Inc. · 2003-09-05K993425PRIMUSSiemens Medical Solutions USA, Inc. · 1999-11-26K982502GENESIS IMRT LINEAR ACCELERATORSiemens Medical Solutions USA, Inc. · 1998-07-31

Official Source

View FDA Recall →

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

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