Siemens Medical Solutions USA, Inc. recalls ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy guidelines 6C1HD - model numbers: 1044200…

Recall date

June 29, 2015

Source

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

Recall number

Z-2344-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

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, Egyp…

Why it was recalled

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.

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 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.