Recall Z-1832-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
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 calculatio
| Date | Mar 28, 2011 (initiated Mar 1, 2010) |
| Status | Terminated |
| Reason | "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." |
| Root cause | Software design |
| 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. |
| Quantity | 1903 |
| Distribution | 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, Indone |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093812 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Mar 3, 2010 |