Recall Z-2876-2016— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2876-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-26

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2016-07-26, terminated 2018-05-10. It names one FDA 510(k) clearance: K103606. Product: ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.. Reason: Software patch installation to address several safety issues..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-26
Terminated: 2018-05-10
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K103606 — ARTISTE SOLUTION WITH SYS_VB50 UPDATESiemens Medical Solutions USA, Inc.·cleared 2011-04-15

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

ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

Reason for recall

Software patch installation to address several safety issues.

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