Terminated

Acuson S2000 Ultrasound System with software and imaging. The Acuson S2000 ultrasound imaging systems are intended for these applications: fetal, abdominal, intraoperative, pediatric, small parts, transcranial, OB/GYN, cardiac, pelvic, neonatal/adult cephalic, vascular, musculoskeletal, superficial musculoskeletal, and peripheral vascular applications. Also for anatomical structures and calculation packages that provide information that provide information to the clinician...for clinical diagnosis purposes.

FDA Recall Z-1832-2011 · Posted 2011-03-28

Recalling FirmSiemens Medical Solutions USA, Inc.

Recall StatusTerminated

Product CodeIYN

Date Initiated2010-03-01

Date Terminated2012-06-18

Product Quantity1903

Reason for Recall

"Any 2D measurement performed in Exam Review or offline, on a zoomed Retrospective clip capture may be erroneous. This applies to 2D, 2D/PW, 2D/CW and 2D/M-mode."

Firm Action

Siemens Medical Solutions USA, Inc. sent a Consumer Safety Advisory Notification letter on February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the Customer Safety Notice to all those within their organization who need to be aware of the issue until the corrective action was completed. For questions regarding this recall call 650-694-5580.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of United Arab Emirates, Australia, Belgium, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Ecuador, Eguypt, Spain, Finald, France, Great Britian, Germany, Hong Kong, Croatia, Indonesia, Ireland, Israel, India, Ireland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Lithuania, Mexico, Malaysia, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Slovenia, Slovak Republic, Thailand, Turkmenistan, Tunisia, Turkey, Taiwan, Ukraine, Venezeula, Yemen, and South Africa..

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093812ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc. · 2010-03-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.