Recall Z-1423-2010 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Imaging XS model number 10496279 The intended use: image processing radiological
| Date | Apr 20, 2010 (initiated Feb 16, 2010) |
| Status | Terminated |
| Reason | images can be overwritten |
| Root cause | Software design |
| Action | A "Customer (Safety) Advisory notice" dated February 16, 2010, was sent all affected customers via Update Instructions IM019/10/S. This notice describes the product, problem and the action to be taken by the customers. The customers should immediately instruct their employees of the advisor notice and maintain awareness. If the customer sold the device/equipment and is no longer in possession of it, they should forward the notice and inform Siemens of the new owner. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected system |
| Quantity | 6 units |
| Distribution | Nationwide distribution: CA, NC, NY, PA, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082430 | SYNGO IMAGING XS Siemens AG Medical Solutions, Nov 14, 2008 |