Device recall

Z-1853-2011: Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.

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

Key facts

Recall number (Z-number) Z-1853-2011
Recall event 54844
Product Acuson Antares Ultrasound Imaging System with software versions 4.0 and 5.0.
Product code IYN
Recalling firm Siemens Medical Solutions USA, Inc.
Recall class Class II
Status Terminated
Termination date Jun 18, 2012
510(k) numbers K023720, K033196, K050034, K063803
FEI number 2936884

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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