Events

Recall of Biograph 16 TruePoint TV

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
    74192
  • Event Risk Class
    Class 2
  • Event Number
    Z-2006-2016
  • Event Initiated Date
    2016-04-22
  • Event Date Posted
    2016-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146699
  • 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, molecular imaging has become aware of a potential for unexpected suv values if a non-siemens phantom is used for calibration.
  • Action
    Siemens sent a Customer Safety Advisory Letter on April 22, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens representative at the contact numbers provided in the letter.

Device

Biograph 16 TruePoint TV
  • Model / Serial
    Serial Numbers: 72405,72408,72409,72411,72412,72413,72415,72416,72423,72430,72438,72439,72446,72447,72449,72451,72452,72454,72456,72458,72462,72463,72469,72473,72478,72482,72483,72488,72490,72500,72506,72507,72508,72510,72516,72536
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Biograph 16 TruePoint TV, Material Number 10249556 || The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
  • Manufacturer
    Siemens Medical Solutions USA Inc.

Manufacturer

Siemens Medical Solutions USA Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA Inc., 810 Innovation Dr, Knoxville TN 37932-2562
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA