Device recall

Z-0052-2014: Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg…

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

Key facts

Recall number (Z-number) Z-0052-2014
Recall event 65812
Product Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc. Mountain View, CA 94043 Medical Device for human use. Ultrasound imaging system used to measure anatomical structures and calculation packages that provide information to the…
Product code IYN
Recalling firm Siemens Medical Solutions USA, Inc.
Recall class Class II
Status Terminated
Termination date Nov 25, 2013
510(k) numbers K123622
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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