Siemens Medical Solutions USA, Inc. recalls The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or…

Recall date

December 31, 2015

Source

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

Recall number

Z-0687-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc.

Sold / distributed

Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.

Why it was recalled

To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished and shipped to the customer.

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

What was recalled

The e.cam Dual Signature Gamma Camera 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.