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Siemens Medical Solutions USA, Inc. recalls ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 1044
Recalled August 12, 2015 · FDA recall Z-2344-2015 · Siemens Medical Solutions USA
Hazard
When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the on-screen guidelines. · FDA Class II
Units
4140 total
Sold at
Worldwide Distribution - US Nationwide and the countries of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Brazil, Brunei, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Dem. Rep. Congo, Denmark, Dominican Rep., Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Venezuela and Vietnam.
Description
When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guidelines, the biopsy needle may traverse outside the on-screen guidelines.
Product
ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 10442008 6C1HD Needle Guide, S3000; 10440586 6C1 HD Biopsy Guide, S2000 18L6 - model numbers: 10442007 18L6 Biopsy Guide, S3000 10044200 S2000 Biopsy Starter Kit, 18L6 HD 10855189 18L6 HD Biopsy Starter Kit, S1000 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →