Recall Z-1581-2015 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: 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 Convention
| Date | May 5, 2015 (initiated May 11, 2012) |
| Status | Terminated |
| Reason | In some cases, the system is unable to capture a clip or image during a routine scan. |
| Root cause | Other |
| Action | Siemens sent a Customer Advisory Notice letter to affected customers. The letter identified the affected product. problem and how this issue is being resolved. To resolve this issue on all affected systems, a mandatory software update has been developed and is being installed free of charge. |
| Quantity | 186 devices |
| Distribution | Worldwide Distribution - US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kazakhstan, Kenya, Kuwait, Mauritius, Mexico, Norway, Oman, P.R. China, Poland, Rep. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123622 | ACUSON Siemens Medical Solutions USA, Inc., Dec 5, 2012 |