Recall Z-1601-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
| Date | May 4, 2016 (initiated Apr 14, 2016) |
| Status | Terminated |
| Reason | Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the entire section of the report including data from previous studies. This may result in the physician making analysis based on the old measurements. |
| Root cause | Software design |
| Action | Siemens mailed out a "Customer Advisory Notice" #SY009/16/P to customers informing them of the issue and what to do if it was to occur. Siemens informed customers that they are working on the "carry forward" feature enhancement and is planning to release a software update VA10B_HF06 and they should follow the instructions in the advisory notice until the update is performed. |
| Quantity | 84 units |
| Distribution | Nationwide: AZ, CA, IL, IN, MA, MD, MI, MN, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023772 | KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Acuson Corp., Nov 22, 2002 |