Device Recall e.cam Dual Signature; Gamma Camera

  • Model / Serial
    e.cam systems that were refurbished from 04/06/15 to 10/06/15. Material number 10151531, serial number 70004; Material number 10151532 serial numbers 70038, 70040, 70041, 70042, 70043, 70044, 70039, 70045, and 70046.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of Florida, New York, Indiana, Maryland, South Dakota, Missouri, Tennessee, and Georgia, and the countries of Australia and India.
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60192-2061
  • Manufacturer Parent Company (2017)
  • Source
    USFDA