Acuson SC2000 volume imaging ultrasound systems recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

In some cases, the system is unable to capture a clip or image during a routine scan.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. 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. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;

Where it was distributed

Worldwide Distribution - US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kazakhstan, Kenya, Kuwait, Mauritius, Mexico, Norway, Oman, P.R. China, Poland, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom.

Nationwide