PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 27, 2016 Initiated: December 31, 2015 #Z-0687-2016

Product Description

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.

Reason for Recall

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.

Details

Units Affected
10
Distribution
Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.
Location
Hoffman Estates, IL

Frequently Asked Questions

What product 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.. Recalled by Siemens Medical Solutions USA, Inc.. Units affected: 10.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 27, 2016. Severity: Moderate. Recall number: Z-0687-2016.