Recall Z-1064-2012 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Siemens syngo Imaging XS. Radiological image processing system.
| Date | Feb 20, 2012 (initiated Jan 26, 2012) |
| Status | Terminated |
| Reason | In September 2011 firm issued two Customer Safety Advisory Notices for syngo Imaging XS. Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using the thumbnails may cause unintended deletion of images/series. In response, firm issued a Customer Safety Advisor |
| Root cause | Software design |
| Action | Siemens Medical issued an "UPDATE INSTRUCTIONS SY055/11/S/UPDATE PACKAGE VA70B_0211" to all affected customers. The package described the product, problem, and instructions for customers to follow. |
| Quantity | 128 |
| Distribution | Nationwide Distribution-including the states of CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082430 | SYNGO IMAGING XS Siemens AG Medical Solutions, Nov 14, 2008 |