Recall Z-1349-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
| Date | Apr 7, 2016 (initiated Jan 18, 2016) |
| Status | Terminated |
| Reason | To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging. |
| Root cause | Software design |
| Action | Siemens mailed a Customer Advisory Notice to their customers instructing them to check their modalities for the usage of the mentioned DICOM attributes with different values. They recommended upgrading the workplace(s) to syngo Imaging Studio version VB36D if they have such modalities and it cannot be ensured by the modality provider that only one attribute is filled or both attributes are filled with the same value. Customers were asked to contact their local service organization to clarify the compatibility of their syngo Imaging server version with workplace version VB36D. |
| Quantity | 49 imaging systems |
| Distribution | US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI. |
| FDA record | Open on fda.gov |