Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163
FDA device recall Z-1095-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- 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.
- Date initiated
- 2004-04-01
- Date posted
- 2004-07-20
- Date terminated
- 2004-09-21
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE (K935694) | Siemens Medical Solutions USA, Inc. | 1994-03-07 |