Siemens Medical Solutions USA, Inc. recalls ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is in…

Recall date

January 12, 2015

Source

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

Recall number

Z-1056-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution - USA and the countries of Australia, Austria, Belarus, Canada, Ecuador, Finland, France, Georgia, Germany, India, Iraq, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, P.R. China, Philippines, Portugal, Republic Korea, Russian Fed., Saudi Arabia, Serbia, South Afr…

Why it was recalled

The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Control panel cannot be locked into position.

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, Model 10433816, component 10040596 - UILK2. 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.