Recall Z-0794-06 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM CT System Sensation 16. Computed tomography x-ray system.
| Date | Apr 26, 2006 (initiated Mar 9, 2006) |
| Status | Terminated |
| Reason | When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved. |
| Root cause | Other |
| Action | The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue. |
| Quantity | 5 units |
| Distribution | Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013522 | SOMATOM P30 CT SYSTEMS Siemens Medical Systems, Inc., Nov 7, 2001 |