—#45095

Product

SOMATOM Sensation CT Systems

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: Sensation 10 model number 7543015, Sensation 16 model number 7393114, Sensation 64 model number 8377520, and Sensation Open model number 8872017. Software versions CT2006A and CT2006G.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2006-03-17
Posted by FDA: 2006-04-26
Terminated: 2008-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45095. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.