Recall Z-1095-04 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163
| Date | Jul 20, 2004 (initiated Apr 1, 2004) |
| Status | Terminated |
| Reason | Recalling firm became aware of a potential problem through the submission of a product complaint to the firm reporting the Image Navigator feature in the MagicView 300 VA42A or VA42B software are not being imported accurately to certain CT or MR images. |
| Root cause | Other |
| Action | The recalling firm has issued a letter to their Siemens Service Engineers to visit each affected sites, in order to correct the software problems. Additionally, a letter advising of the software problems was also sent to the Radiology Director at the affected sites, informing them of the 'Customer Safety Advisory' and the pending visit of the Seimens Service Engineers to perform a software update. Along with these letters, is a set of instructions detailing the potential risks and that a representative from the recalling firm will be contacting the medical facilities. |
| Distribution | Nationwide. The product was shipped to various medical facilities, in the following states, AK, GA, FL, IA, MA, MI, MO, NH, NJ, NY, NV, OK, PA, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935694 | SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE Siemens Medical Solutions USA, Inc., Mar 7, 1994 |