Device recall

Z-0299-2019: Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number…

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

Key facts

Recall number (Z-number) Z-0299-2019
Recall event 80960
Product Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used for radiographic and tomographic exposures of the whole body.
Product code KPR
Recalling firm Siemens Medical Solutions USA, Inc
Recall class Class II
Status Terminated
Termination date Apr 10, 2020
510(k) numbers K081722
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)