Device recall

Z-0604-2017: SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM…

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

Key facts

Recall number (Z-number) Z-0604-2017
Recall event 75555
Product SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
Product code JAK
Recalling firm Siemens Medical Solutions USA, Inc
Recall class Class II
Status Terminated
Termination date Mar 13, 2017
510(k) numbers K143400
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)