E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2898-2020.
E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may lose some detector time information. Our risk analysis indicates that the probability of occurrence is remote. SPECT: 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. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2898-2020.
Recall terminated by FDA.
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- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2898-2020.
Siemens Medical Solutions USA, Inc.
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Siemens Medical Solutions Usa, Inc. Recall FAQ
Siemens Medical Solutions Usa, Inc. is the subject of a medical devices safety report: E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or.... The notice was published on March 31, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 5,066 units are potentially affected.