Device recall

Z-1398-2018: ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage…

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

Key facts

Recall number (Z-number) Z-1398-2018
Recall event 79766
Product ONCOR Avant-garde, Digital Linear Accelerator, Model No. 05863472 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Product code IYE
Recalling firm Siemens Medical Solutions USA, Inc
Recall class Class II
Status Terminated
Termination date May 16, 2019
510(k) numbers K031764
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)