Recall Z-2078-2012 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Siemens syngo.plaza. Radiological image processing system
| Date | Jul 26, 2012 (initiated Feb 24, 2012) |
| Status | Terminated |
| Reason | Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to user. |
| Root cause | Software design |
| Action | Siemens sent a Customer Safety Advisory Notice letter dated February 24, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to ensure that the prefix defined in the viewer settings for "Content Creator's Initials" is not empty. Then all images will be display correctly. This has to be checked for every user. Further questions please call 610-219-6300. |
| Quantity | 2 |
| Distribution | (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101666 | SYNGO. PLAZA VA20A Siemens AG Medical Solutions, Aug 10, 2010 |