Recall Z-0102-2009 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.
| Date | Oct 15, 2008 (initiated Aug 22, 2008) |
| Status | Terminated |
| Reason | Image may not be visible after merge. |
| Root cause | Software design |
| Action | The recalling firm issued Customer Safety Advisory Notice dated 8/22/08 to inform the consignees of the potential issue and provide instruction to avoid its occurrence. To avoid potential risk of this issue, users are asked to check whether the extended HL7 messages as stated in the letter are mandatory for their RIS-PACS workflow, and disable these messages if they are not. Siemens is preparing a modification under the UI IM086/08/S for the affected versions of syngo Imaging that will resolve the potential malfunction. The field modification will be immediately distributed and installed by |
| Quantity | 59 units |
| Distribution | Nationwide Distribution --- including states of AL, AZ, CA, CO, CT, FL, IA, KS, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, TN, TX, and WI. |
| FDA record | Open on fda.gov |