Device recall

Z-0985-2019: Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max…

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

Key facts

Recall number (Z-number) Z-0985-2019
Recall event 82211
Product Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Omnia Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Product code OWB
Recalling firm Siemens Medical Solutions USA, Inc
Recall class Class II
Status Terminated
Termination date May 5, 2020
510(k) numbers K173639
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

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