Recall Z-0092-06 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Sienet Cosmos. Radiological Image Processing. Model number 10018971
| Date | Oct 28, 2005 (initiated Sep 22, 2005) |
| Status | Terminated |
| Reason | reference lines appear above actual position |
| Root cause | Other |
| Action | The company has issued a Customer Safety Advisory dated 9/22/05 via certified mail to the affected customers per Update Instructions CN038/05/S. The letter informs customers of the issue and also provides customer with instruction to avoid its occurrence. |
| Quantity | 64 units |
| Distribution | The product was shipped to medical facilities in CA, CO, FL, IA, KS, LA, MD, MI, MO, NC, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042832 | SIENET COSMOS (VERSION V15A) Siemens AG Medical Solutions, Oct 28, 2004 |