Events

Recall of Device Recall Symbia Intevo 6

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
    78184
  • Event Risk Class
    Class 2
  • Event Number
    Z-0094-2018
  • Event Initiated Date
    2017-11-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158854
  • 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
    The broad quantification option of the symbia product software version vb20a may not allow modification of two data input values. the failure occurs when the system with the broad quantification option is calibrated with phantoms that do not have a volume of 6500ml and/or when residual dose needs to be entered.
  • Action
    Siemens Healthineers sent a Customer Safety Advisory Notice Letter to each impacted consignee beginning on November 07, 2017. Depending on the customer's capabilities, Siemens provides the letters via mail, e-mail, or hand delivery by a service engineer. The receipt of the letter will be documented and additional attempts will be made until such receipt is acknowledged. Certified mail will be used to track the submission of the letter. Certified mail receipts will be obtained for each customer. Adobe e-signature will be obtained from the customers receiving the Customer Advisory Letter via email. Unsuccessful delivery will be documented and a field service engineer will be dispatched to the site to deliver the letter and applicable information. Customers were advised to please ensure that this customer advisory notice is placed in your system with the Broad Quantification option Operators Manual and disseminated to all operators of the system with the Broad Quantification option system. If this equipment is no longer in your possession, we kindly ask that you forward this letter to the new owner of the equipment, and please inform Siemens about the change in ownership. Adverse events or quality problems experienced with the use of this product should be reported to Siemens through the contact information provided below and may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you have any questions regarding this advisory notice, please contact your local Siemens representative at the contact numbers provided below. " America: 1-800-888-7436 " Europe, Middle East, and Africa: +49 9131 940 4000 " Asia and Australia: +86 (21) 3811 2121

Device

Device Recall Symbia Intevo 6
  • Model / Serial
    Serial Number: 2141, 2144
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution to Malaysia, France, Japan, Reunion Island
  • Product Description
    Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System || 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. 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. These systems are intended to be utilized 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.
  • 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 60192-2061
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA