Device recall

Z-0827-2011: ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business…

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

Key facts

Recall number (Z-number) Z-0827-2011
Recall event 57289
Product ACUSON SC 2000 ultrasound system. Siemens Medical Solutions USA, Inc. Business Unit Ultrasound 1230 Shorebird Way Mountain View, CA 94043 Intended use: SC2000 ultrasound system is intended for the following applications: Cardiac, neo-Natal and fetal Cardiac, Pediatric, Transesophageal, Adult…
Product code IYN
Recalling firm Siemens Medical Solutions USA, Inc.
Recall class Class II
Status Terminated
Termination date Oct 4, 2011
510(k) numbers K072365
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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