Recall Z-1975-2013 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
| Date | Aug 15, 2013 (initiated Mar 4, 2013) |
| Status | Terminated |
| Reason | Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments. |
| Root cause | Software design |
| Action | The firm, Siemens, notified their customers on March 4, 2013 and sent a "Customer Safety Advisory Notice" letter dated April 03, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to always check whether the laterality information is displayed in the image text of mammography images; if not, the DICOM header is accessible and can be checked for the tag "Laterality" (0020, 0060). If a system is not able to provide the DICOM tag "Image Laterality" (0020, 0062), configuring the image text by adding the tag was proposed. If you have sold the devi |
| Quantity | 6 |
| Distribution | Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093612 | SYNGO.PLAZA Siemens AG Medical Solutions, Mar 4, 2010 |