Recall Z-2147-2011 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Siemens Medical Solutions USA, Inc.
Siemens ACUSON X300 Systems with software versions 3.0.00 and 3.0.02, model numbers 10348531, 10348532 and 10348533, manufactured by Siemens Medical Solutions, Mountain View, CA. Intended for General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial M
| Date | May 6, 2011 (initiated Jul 24, 2009) |
| Status | Terminated |
| Reason | Mistreatment risk-- when a user defined formula is used to calculate a value in a vascular exam, data is switched laterally when it is internally transferred and displayed on the summary report within the system. |
| Root cause | Software design |
| Action | A field correction was initiated and a Customer Safety Advisory Notification was sent out on 7/29/09. The letter identified the affected product and stated that there was a potential for user defined calculations to be incorrect within the vascular package when using the listed software versions of the product. The letter also discussed the steps that customers could take to avoid the potential risk of the issue. A mandatory update software was developed and will be installed free of charge. Customers should have been contacted to schedule a time for the installation. Questions were to be |
| Quantity | 154 units |
| Distribution | Worldwide Distribution -- Austria, Brazil, China, Columbia, Germany, Denmark, Egypt, Great Britain, Honduras, Ireland, India, Italy Japan, South Korea, Mexico, Malaysia, Peru, Poland, Portugal, Romania, Russia, Sweden, Singapore, Thailand, Turkey, Taiwan, United States, Uruguay, Venezuela, and South |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072676 | ACUSON X300 ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Dec 18, 2007 |