Device recall

Z-2887-2020: Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios…

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

Key facts

Recall number (Z-number) Z-2887-2020
Recall event 86166
Product Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Product code OWB
Recalling firm Siemens Medical Solutions USA, Inc
Recall class Class II
Status Terminated
Termination date May 20, 2021
510(k) numbers K181560
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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