Events

Recall of GE Innova 3100

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
    53260
  • Event Risk Class
    Class 2
  • Event Number
    Z-1688-2009
  • Event Initiated Date
    2008-10-09
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85118
  • 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
    Solid State X-Ray Imager - Product Code MQB
  • Reason
    Ge healthcare has become aware of an air kerma rate issue associated with a large equivalent patient thickness (ept) on the innova system that my impact patient safety. during a maximum air kerma rate (akr) calibration procedure check, ge healthcare found the akr calibration procedure does not exactly reflect the worst-case clinical usage of the product. this may result, when using large equival.
  • Action
    Consignees were sent a GE Healthcare "Important electronic Product Radiation Warning" letter dated November 3, 2008. The letter was addressed to Healthcare Administrator/Risk Managers, Managers of Radiology/Cardiology, Radiologists/Cardiologists. The letter described the Defect Description and Related Hazards, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For further information, contact the GE Healthcare Technical Support Center at 1-800-437-1171.

Device

GE Innova 3100
  • Model / Serial
    Serial Numbers: 00000529517BU5 00000458534BU5 00000435031BU0 00000566382BU8 00000512956BU4 00000550134BU1 00000549706BU0 00000523132BU9 00000537463BU2 00000547770BU8 00000446090BU3 00000491058BU4 00000537465BU7 00000476260BU5 00000530412BU6 00000555080BU1 00000437215BU7 00000465048BU7 00000482707BU7 00000541969BU2 00000488003BU5 00000545420BU2 00000556280BU6 00000484393BU4 00000544285BU0 00000523134BU5 00000477394BU1 00000482419BU9 00000551636BU4 00000509132BU7 00000568027BU7 00000543272BU9 00000545590BU2 00000548338BU3 00000482661BU6 00000440229BU3 00000521654BU4 00000544808BU9 00000565460BU3 00000520189BU2 00000512758BU4 00000509817BU3 00000545421BU0 00000482188BU0 00000477767BU8 00000557461BU1 00000445301BU5 00000543795BU9 00000424103BU0 00000545419BU4 00000454181BU9 00000449819BU2 00000463520BU7 00000552743BU7 00000548601BU4 00000442172BU3 00451726BU4BU8 00000497601BU5 00000438668BU6 00000492274BU6 00000505219BU6 00000567995BU6 00000571256BU7 00000465766BU4 00000466810BU9 00000553071BU2 00000511912BU8 00000543120BU0 00000552383BU2 00000512958BU0 00000556788BU8 00000464558BU6 00000466829BU9 00000533868BU6 00000548599BU0 00000520410BU2 00000463833BU4 00000570110BU7 00000549016BU4 00000546576BU0 00000470050BU6 00000544812BU1 00000510017BU7 00000548838BU2 00000557169BU0 00000449428BU2 00000496906BU9 00000570359BU0 00000443952BU7 00000437218BU1 00000461906BU0 00000544203BU3 00000434779BU5 00000505176BU8 00000446502BU7 00000496041BU5 00000521649BU4 00000492423BU9 00000484907BU1 00000485033BU5 00000487475BU6 00000520970BU5 00000463464BU8 00000553267BU6 00000547211BU3 00000545045BU7 00000524175BU7 00000493821BU3 00000558167BU3 00000523775BU5 00000570104BU0 00000452492BU2 00000485087BU1 00000450075BU7 00000479764BU3 00000434782BU9 00000537446BU7 00000452493BU0 00000460068BU0 00000570350BU9 00000558166BU5 00000568028BU5 00000556511BU4 00000459558BU3 00000543264BU6 00000557172BU4 00000514330BU0 00000509481BU8 00000479441BU7 00000479625BU6 00000556987BU6 00000544976BU4 00000441966BU9 00000467462BU8 00000459647BU4 00000467645BU8 00000463372BU3 00000539717BU9 00000461405BU3 00000557170BU8 00000439643BU8 00000460292BU6 00000514047BU0 00000445175BU3 00000485405BU5 00000531110BU5 00000047210BU7 00000479704BU9 00000433021BU3 00000557460BU3 00000555006BU6 00000548594BU1 00000538051BU4 00000447647BU9 00000548331BU8 00000423871BU3 00000429683BU6 00000438670BU2 00000498017BU3 00000547293BU1 00000567353BU8 00000447877BU2 00000555007BU4 00000560234BU7 00000546435BU9 00000460426BU0 00000552103BU4 00000552056BU4 00000512955BU6 00000568031BU9 00000521645BU2 00000514742BU6 00000457662BU5 00000547956BU3 00000518370BU2 00000458814BU1 00000458106BU2 00000499841BU5 00000490965BU1 00000423793BU9 00004994239BU2 00000438965BU6 00000439427BU6 00000453192BU7 00000441134BU4 00000546573BU7 00000566842BU1 00000553072BU0 00000435189BU6 00000551947BU5 00000538571BU1 00000541274BU7 00000548333BU4 00000463834BU2 00000558903BU1 00000554126BU3 00000512762BU6 00000546170BU2 00000544809BU7 00000511597BU7 00000553274BU2 00000546155BU3 00000453193BU5 00000430039BU8 00000469683BU7 00000424074BU3 00000555010BU8 00000553070BU4 00000557462BU9 00000555539BU6 00000552744BU5 00000458137BU7 00000449784BU8 00000569365BU0 00000524362BU1 00000454140BU5 00000493965BU8 00000529520BU9 00000571896BU0 00000427535BU0 00000453099BU4 00000439642BU0 00000539716BU1 00000482662BU4 00000452732BU1 00000478102BU7 00000570354BU1 00000441662BU4 00000512465BU6 00000555540BU4 00000534470BU0 00000553801BU2 00000548335BU9 00000459460BU2 00000490237BU5 00000510040BU9 00000557175BU7 00000434731BU6 00000556514BU8 00000479728BU8 00000571258BU3 00000443948BU5 00000450033BU6 00000559817BU2 00000533869BU4 00000480177BU5 00000551077BU1 00000007C20165 00000546032BU4 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and 00000563637BU8.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- United States including Puerto Rico and Guam.
  • Product Description
    GE Innova 3100, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). || Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
  • Manufacturer
    Ge Healthcare

Manufacturer

Ge Healthcare
  • Manufacturer Address
    Ge Healthcare, 9900 W Innovation Dr, Wauwatosa WI 53226-4856
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA