Recall Z-0324-2009 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system.
| Date | Dec 3, 2008 (initiated Sep 12, 2008) |
| Status | Terminated |
| Reason | Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected. |
| Root cause | Software design |
| Action | The recalling firm has issued a software update to affected customers via Update Instructions CT034/08/S. This software update corrects the values from the volume perfusion post processing application. A firm representative will visit each consignee to install the software update beginning 9/12/08. |
| Quantity | 130 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010938 | SYNGO MULTIMODALITY WORKSTATION Siemens Medical Solutions USA, Inc., Jun 26, 2001 |