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 org…

Recall date

April 8, 2014

Source

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

Recall number

Z-0914-2015

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Worldwide Distribution: US (nationwide) including states of: AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY and Puerto Rico; and countries of: Algeria , Angola , Argentina , Austr…

Why it was recalled

There is a potential for patient finger injury on the e.cam systems.

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 588keV.