Nationwide and worldwide. The product received nationwide distribution to 123 consignees: 23 Distributors (50 transducers) and consumers/users: approximately 100 customers (146 transducers). 2 transducers were consigned to Federal Government locations: (1) Martin Army Community Hospital, 9200 Marne Rd., Fort Benning, GA 31905, (2) Lackland AFB, Wilford Hall, 2200 Bergquist Dr., #100, Lackland AFB, TX 78236. The firm has also distributed product into international channels through distributors. Countries include, Austria; Barbados; Brazil; Canada; China (PRC); Egypt, France, Germany; Greece; India; Italy; Japan; South Korea; Netherlands; Russia; Saudi Arabia; Sweden; Taiwan; and United Kingdom. There is no Canadian distribution. The firm is continuing to obtain the international distribution through the distributors. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, and users who received the recalled product.
Product Description
Acuson Diagnostic Ultrasound System Transducer; || Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; || Catalog Numbers: 23656 (New), 45441 (Refurb)
Worldwide Distribution -- US, including the states of TX and MN, and the territory of P.R.; and, the countries of China, Germany, Russian Fed, Saudi Arabia, Taiwan, France, Thailand, and Italy.
Product Description
ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. || The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. || The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
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 Africa, Spain, Suriname, Sweden, Taiwan, Turkey, U.A.E. and United Kingdom.
Product Description
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.
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.
Product Description
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;
Worldwide Distribution -- US and Albania, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, P.R. China, Philippines, Portugal, Rep. of Yemen, Republic Korea, Russian Fed., San Marino, Saudi Arabia, Singapore, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, and Venezuela.
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.
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, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lithuania, Malaysia, Maldives, Mauritius, Mexico, Netherlands, Nigeria, Oman, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed, San Marino, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom and Venezuela
Product Description
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.