Events

Recall of XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

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
    56818
  • Event Risk Class
    Class 2
  • Event Number
    Z-0537-2011
  • Event Initiated Date
    2010-10-27
  • Event Date Posted
    2010-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94580
  • 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, image processing, radiological - Product Code LLZ
  • Reason
    Ge healthcare has become aware of inaccurate user protocol setup associated with the thyroid uptake index application on certain xeleris workstations(1.0, 1.1, 2.0, 2.1) that may impact patient safety. inaccurate protocol setup by the user while using thyroid uptake index application has been identified on certain xeleris workstations. incorrect protocol setup during clinical data acquisition a.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated October 27, 2010, to all consignees. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology and Radiologists/Cardiologists and Identifed the product, the problem and the action to be taken by the consignees. Consignees were instructed to replace the original protocol instructions provided with their system with the updated protocol instructions provided with the letter. For any questions consignees were to contact their local GE Healthcare Service Representative or contact the GE Healthcare Call Center: United States or Canada (800) 437-1171 Other countries: (262) 896-2890

Device

XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    All States in continental USA including DC and PR. Viet Nam, Venezuela, Uruguay, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Sweden, Spain, South Africa, Slovakia, Singapore, Saudi Arabia, Russian Federation, Republic of Korea, Portugal, Poland, Philippines, Panama, Pakistan, Norway, New Zealand, Netherlands, Morocco, Mexico, Martinique, Malaysia, Luxembourg, Kuwait, Kenya, Japan, Jamaica, Italy, Israel, Ireland, Indonesia, India, Hungary, Hong Kong, Guadeloupe, Greece, Germany, France, Finland, Ecuador, Dominican Republic, Cyprus, Colombia, China, Canada, Bulgaria, Brazil, Bosnia & Herzegovina, Belgium, Azerbaijan, Austria, Australia, Argentina, Algeria.
  • Product Description
    XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION || The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT) imaging, positron imaging by coincidence, attenuation correction, and anatomical image registration.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA