Recall Z-1059-2015— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1059-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-12-19, terminated 2017-01-26. It names 5 FDA 510(k) clearances: K072485, K060226, K031764 and 2 more. Product: 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.. Reason: 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..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Terminated: 2017-01-26
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

5 on FDA's record

K072485 — ARTISTE MV SASiemens Medical Solutions USA, Inc.·cleared 2007-12-27
K060226 — ONCOR EXPRESSIONSiemens Medical Solutions USA, Inc.·cleared 2006-03-15
K031764 — ONCOR AVANT-GARDE WITH COHERENCE WORKSPACESSiemens Medical Solutions USA, Inc.·cleared 2003-09-05
K993425 — PRIMUSSiemens Medical Solutions USA, Inc.·cleared 1999-11-26
K982502 — GENESIS IMRT LINEAR ACCELERATORSiemens Medical Solutions USA, Inc.·cleared 1998-07-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.