Events

Recall of Symbia Intevo Excel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69114
  • Event Risk Class
    Class 2
  • Event Number
    Z-0913-2015
  • Event Initiated Date
    2014-08-12
  • Event Date Posted
    2015-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129665
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, tomography, computed, emission - Product Code KPS
  • Reason
    Siemens medical solutions usa, inc. has received reports of unintended radial motion of the detectors. this unintended motion, should it occur, may cause the patient compression related injuries.
  • Action
    Siemens sent Customer Safety Advisory Notice letters to all customers of record. The letters instructed customers to: 1) continue to use their system(s); 2) place the safety advisory in the system's instructions for use; and, 3) to anticipate that their local service engineer will contact them to perform an inspection and schedule any necessary repairs by December 2014. Customers were also instructed to share the letter with their support staff and, if the equipment was sold or transferred, to forward the safety notice to the new owner of the equipment. Customers with questions can contact their local service representative or Siemens Medical Solutions at 800-888-7436.

Device

Symbia Intevo Excel
  • Model / Serial
    1) Symbia Intevo 6: Product Number: 10764803; Serial Numbers: 1001 ; 1002 ;  2) Symbia Intevo 16; Product Number: 10764804; Serial Numbers: 1001 ; 1002 ;  3) Symbia Intevo Excel; Product Number: 10764801; Serial Numbers: 1001 ; 1002
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (naitonwide) and Internationally to Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lithuania, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
  • Product Description
    The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. || The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. || The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. || 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 5S8keV. || 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 plane taken at different angles or spiral planes taken at different angles. || SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. || Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA