Events

Recall of GE Definium 8000

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

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
    49388
  • Event Risk Class
    Class 2
  • Event Number
    Z-1476-2008
  • Event Initiated Date
    2007-08-13
  • Event Date Posted
    2008-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73238
  • 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
    Image-intensified fluoroscopic x-ray system. - Product Code JAA
  • Reason
    Necessary certification labels are missing from the x-ray contol.
  • Action
    A field Engineer from GE will visit the customer site to apply label to the X-ray control.

Device

GE Definium 8000
  • Model / Serial
    serial numbers: 0000000002772E, 00000001191M36, 00000002065M31, 00000002650M30, 00000002753EN2, 00000002767EN2, 00000002968M36, 00000003505M35, 00000003806M37, 00000004101M32, 00000004547M36, 00000005487M34, 00000096383DP5, 00000097656DP3, 00000100740WK6, 00000114297VE5, 00000989905WK5, 00000992237WK8, 00000992321WK0, 00000992949WK8, 00000992952WK2, 00000993284WK9, 00000993807WK7, 00000994376WK2, 00000994685WK6, 00000994845WK6, 00000995791WK1, 00000995797WK8, 00000995798WK6, 00000995799WK4, 00000996181WK4, 00000996289WK5, 00000996290WK3, 00000996629WK2, 00000996739WK9, 00000996745WK6, 00000996977WK5, 00000997197WK9, 00000997198WK7, 00000997265WK4, 00000997333WK0, 00000997803WK2, 00000997808WK1, 00000997809WK9, 00000997885WK9, 00000997887WK5, 00000998455WK0, 00000998632WK4, 00000TA42184-1, 00001001026WK2, 00001001592WK3, 00001003410WK6, 00001003576WK4, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004158WK0, 00001004163WK0, 00001004330WK5, 00001004331WK3, 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00001013222WK3, 00001013223WK1, 00001013224WK9, 00001013225WK6, 00001013305WK6, 00001013306WK4 , 00001013334WK6, 00001013335WK3, 00001013336WK1, 00001013337WK9, 00001013621WK6, 00001013622WK4, 00001015809WK5, 00002UA5040SGX, 00002UA52707GV.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.
  • Product Description
    GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.
  • Manufacturer
    GE Healthcare

Manufacturer

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