Device recall

Z-2876-2016: ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded…

FDA device recall · Class II · Siemens Medical Solutions USA, Inc

Key facts

Recall number (Z-number) Z-2876-2016
Recall event 75113
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.
Product code IYE
Recalling firm Siemens Medical Solutions USA, Inc
Recall class Class II
Status Terminated
Termination date May 10, 2018
510(k) numbers K103606
FEI number 2240869

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)