Siemens Medical Solutions USA, Inc. recalls ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following appli…

Recall date

January 26, 2018

Source

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

Recall number

Z-1065-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution - U.S. nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Brazil, Brunei, Canada, Chile, China, Columbia, Ecuador, Egypt, El Salvador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Malaysia, Malta,…

Why it was recalled

The application may underestimate the EROA (Effective Regurgitant Orifice Area) in comparison to the same patient results obtained with the 4Z1c volume transthoracic echocardiography transducer.

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 System Product Usage: 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.