Siemens Medical Solutions USA, Inc. recalls E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or orga…

Recall date

April 11, 2012

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1297-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution-US (nationwide) including the District of Columbia and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV and the countrie…

Why it was recalled

Radial motor drives replaced during a customer service action were incorrectly assembled backwards.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.