Recall Z-1584-2015— Siemens Medical Solutions USA, Inc.

Name: FDA recall Z-1584-2015
Creator: U.S. Food and Drug Administration
Published: 2012-07-11

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc., initiated 2012-07-11, terminated 2015-05-06. It names one FDA 510(k) clearance: K123622. Product: ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.. Reason: In certain situations, loss of post exercise images can occur in Stress Echo..

Recalling firm: Siemens Medical Solutions USA, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-07-11
Terminated: 2015-05-06
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123622 — ACUSONSiemens Medical Solutions USA, Inc.·cleared 2012-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.

Reason for recall

In certain situations, loss of post exercise images can occur in Stress Echo.

Data sourced from openFDA. This site is unofficial and independent of the FDA.