Recall Z-0797-06 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
SOMATOM Sensation CT Systems
| Date | Apr 26, 2006 (initiated Mar 17, 2006) |
| Status | Terminated |
| Reason | Firm became aware of a potential problem that could affect scan results and require patient exam to be repeated when using the customized ECG-gated scan protocols in the CT2006A and CT2006G software of their SOMATOM Sensation CT Systems. |
| Root cause | Other |
| Action | Firm has issued an advisory letter (3/28/2006) to affected customers per Update Instructions CT008/06/S. This letter informs customers about the potential problem and provides instructions to avoid this issue. A Siemens Service Engineer will visit affected sites to hand-deliver this letter and to delete any affected scan protocols, which can then be replaced with default protocols or with new customized protocols. |
| Quantity | 86 |
| Distribution | Nationwide. Product was distributed to medical facilities in AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL IN, KS, KY, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TX, UT and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.