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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
Recalled January 27, 2016 · FDA recall Z-0687-2016 · Siemens Medical Solutions USA
Hazard
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. · FDA Class II
Units
10
Sold at
Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.
Description
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.
Product
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →