Siemens Medical Solutions USA, Inc. recalls ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model numbe…

Recall date

May 29, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1959-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution - US Distribution and to the countries of : Albania, Angola, Armenia, Australia, Austria, Bangladesh, Belarus, Bolivia, Bosnia Herzog, Brazil, Brunei, Bulgaria, Canada, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israe…

Why it was recalled

When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.