Recall Z-1233-2009 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Siemens Medical Solutions USA, Inc
Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900. The device is used for full field digital mammography system.
| Date | May 7, 2009 (initiated Jan 23, 2009) |
| Status | Terminated |
| Reason | Image may appear dark, requiring repeat image acquisition. |
| Root cause | Software design |
| Action | A Customer Safety Advisory Notice dated December 16, 2008 was issued to affected customers via Update Instructions SP040/08/S. The letter described the potential issue and provided instructions to avoid its occurrence. A software update to correct the issue is currently being developed and will be installed on affected systems when it becomes available. |
| Quantity | 497 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.