Recall Z-0319-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Imaging VB36D_HF02. Radiological image processing system.
| Date | Nov 20, 2015 (initiated Oct 28, 2015) |
| Status | Terminated |
| Reason | To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. |
| Root cause | Software change control |
| Action | Siemens sent an Customer Information Letter dated October 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call: (610) 219-6300. |
| Quantity | 3 |
| Distribution | US Distribution to the states of : NC, NE and OH. |
| FDA record | Open on fda.gov |