Events

Recall of Device Recall Biograph Mobile

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
    76228
  • Event Risk Class
    Class 2
  • Event Number
    Z-1422-2017
  • Event Initiated Date
    2017-02-20
  • Event Date Posted
    2017-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152549
  • 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 mobile-specific instructions was not shipped to a limited population of biograph mobile systems.
  • Action
    Siemens sent a Customer Advisory Notice letter on February 20, 2017 to affected customer. The letter identified the affected product, problem and actions to be taken. For questions contact your local Siemens.

Device

Device Recall Biograph Mobile
  • Model / Serial
    1010, 1024, 1038, 44976, 45509, 45530, 45573, 45583, 45601, 45604, 45619, 45621, 45627, 45639, 45640, 45646, 45655, 45658
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - US Nationwide in the states of CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY and the countries of Switzerland, Great Britain, Italy
  • Product Description
    Biograph 6 TruePoint, Material Number 10097289 || The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: || ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and || ¿ Produce cross-sectional images of the body by computer reconstruction of XRay transmission data from either the same axial plan taken at different angles or spiral planes taken at different angles.
  • 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