Device recall

Z-1959-2015: ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and…

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

Key facts

Recall number (Z-number) Z-1959-2015
Recall event 71469
Product ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic…
Product code IYN
Recalling firm Siemens Medical Solutions USA, Inc.
Recall class Class II
Status Terminated
Termination date Mar 9, 2017
FEI number 2936884

At a glance

  • None 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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