Recall Z-1584-2015 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
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 Super
| Date | May 6, 2015 (initiated Jul 11, 2012) |
| Status | Terminated |
| Reason | In certain situations, loss of post exercise images can occur in Stress Echo. |
| Root cause | Other |
| Action | On 07/11/2012 a field corrective action was initiated via update programs US016/12/P to update all affected SC2000 customers to software version VA20C, which contains the fix to the described issue. Each customer received a site visit to install the software update. |
| Quantity | 476 |
| Distribution | 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, Re |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123622 | ACUSON Siemens Medical Solutions USA, Inc., Dec 5, 2012 |