Events

Recall of Device Recall Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0

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
    57159
  • Event Risk Class
    Class 2
  • Event Number
    Z-1250-2011
  • Event Initiated Date
    2011-01-12
  • Event Date Posted
    2011-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95492
  • 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 safety issues relevant for the xeleris workstation 1.0, 1.1, 2.0, 2.1, 3.0: 1. measurements taken on the ct images on the ct system are different from the xeleris workstation 2. inaccurate pet suv values may be calculated when data is retrieved from pacs after being processed in the xeleris. 3. wrong marking of early and late result series on display in bra.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 12, 2011 to all consignees/customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to please ensure that all potential users in their facility are made aware of this safety notification and the recommended actions. A GE Healthcare Service representative will perform the required software update on each affected system. If you have any questions or concerns regarding this notification, contact your local GE Healthcare Service Representative. You may also contact GE Healthcare call center in US or Canada at 800-437-1171 and other countries at 262-896-2890.

Device

Device Recall Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including DC, PR, and Guam; and countries including: AUSTRIA, AUSTRALIA, ARGENTINA, ALGERIA, AZERBAIJAN, BELGIUM, BOSNIA & HERZEGOVIA, BULGARIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, LUXEMBOURG, LEBANON, MALY ASIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, PORTUGAL POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SPAIN, SOUTH AFRICA, SOUTH KOREA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, and VIET NAM.
  • Product Description
    Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 || 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. 3X The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing , archiving, printing, reporting and networking of NM data including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomnographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gammna cameras or PET scanners. The system can run on dedicated workstation or in a server-client configuration. The NM or PET data can be coupled with registered and/or fused CT or MR scans and with physiological signals, in order to: depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes..
  • 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