Events

Recall of Xeleris 2 Processing & 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
    64804
  • Event Risk Class
    Class 2
  • Event Number
    Z-1164-2013
  • Event Initiated Date
    2011-10-06
  • Event Date Posted
    2013-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117103
  • 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 a software issue in your xeleris 2.1 workstation (that is used for processing discovery 530/570 data), that may impact patient safety. on imported ct scans, myocardial perfusion imaging (mpi) studies may create artifacts in attenuation corrected images. this may lead to a potential for misdiagnosis.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter dated October 5, 2011, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to contact their local GE Healthcare Service Representative if they have questions or concerns. They may also contact GE Healthcare Call Center , United States or Canada at 800-437-1171. Other countries 262-896-2890. For questions regarding this recall call 262-513-4122.

Device

Xeleris 2 Processing & Review Workstation
  • Model / Serial
    Mfg Lot or Serial # 0000CZC7105FJM000 00000CZC827NRN000 00000CZC8283V4000 0000CZC8283V47000 0000CZC8283V72001 0000CZC8283TX5001 00000000211423001 0000CZC8161XJT000 0000CZC94154WV003 0000CZC83942HL000 0000CZC8396CC9001
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including GA, and NY; and countries of: Canada, Israel, Italy and Switzerland.
  • Product Description
    GE Healthcare, Xeleris 2 Processing & 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