Events

Recall of GE Innova 4100

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-1690-2009
  • 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=85120
  • 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 4100
  • Model / Serial
    Serial Numbers: 00000486055BU7 00000470682BU6 00000452644BU8 00000569022BU7 00000485314BU9 00000560473BU1 00000567345BU4 00000567343BU9 00000436341BU2 00000420851BU8 00000416960BU3 00000562417BU6 00000569374BU2 00000479929BU2 00000476623BU4 00000444365BU3 00000468194BU6 00000567994BU9 00000442706BU8 00000431433BU2 00000520407BU8 00000556127BU9 00000568032BU7 00000043751BU3 00000438338BU6 00000441169BU0 00000432631BU0 00000510846BU9 00000563629BU5 00000454700BU6 00000423362BU3 00000458514BU7 00000534727BU3 00000477896BU5 00000441137BU7 00000476261BU3 00000470681BU8 00000541065BU9 00000523133BU7 00000553597BU6 00000439213BU0 00000447876BU4 00000542136BU7 00000419171BU4 00000558898BU3 00000543121BU8 00000562972BU0 00000538056BU3 00000560914BU4 00000437342BU9 00000556508BU0 00000544811BU3 00000552740BU3 00000408040BU4 00000563631BU1 00000411137BU3 00000549015BU6 00000437304BU9 00000465557BU7 00000545044BU0 00000421391BU4 00000438667BU8 00000492456BU9 00000560476BU4 00000451589BU6 00000559584BU8 00000529811BU2 00000482326BU6 00000561531BU5 00000428412BU1 00000437511BU9 00000566838BU9 00000505177BU6 00000445906BU1 00000409937BU0 00000486496BU3 00000415776BU4 00000415045BU4 00000422564BU5 00000452175BU3 00000471490BU3 00000452282BU7 00000530409BU2 00000516768BU9 00000510845BU1 00000427056BU7 00000541266BU3 00000568029BU3 00000509480BU0 00000497553BU8 00000537447BU5 00000430867BU2 00000431502BU4 00000452126BU6 00000426557BU5 00000556284BU8 00000421698BU2 00000543267BU9 00000442436BU2 00000415816BU8 00000443912BU1 00000562973BU8 00000533874BU4 00000551079BU7 00000556985BU0 00000485439BU4 00000559114BU4 00000439928BU3 00000421241BU1 00000466809BU1 00000518372BU8 00000433006BU4 00000454264BU3 00000559813BU1 00000456666BU7 00000480416BU7 00000560908BU6 00000464091BU8 00000544286BU8 00000566144BU2 00000561528BU1 00000564504BU9 00000449427BU4 00000417375BU3 00000555655BU0 00000547769BU0 00000512467BU2 00000544636BU4 00000537462BU4 00000452938BU4 00000493964BU1 00000464038BU9 00000429295BU9 00000472254BU2 00000505196BU6 00000548339BU1 00000544973BU1 00000441754BU9 00000459476BU8 00000415698BU0 00000422530BU6 00000421310BU4 00000404441BU8 00000567351BU2 00000468124BU3 00000420529BU0 00000498622BU0 00000427699BU4 00000537466BU5 00000547030BU7 00000423544BU6 00000555082BU7 00000560910BU2 00000451813BU0 00000521653BU6 00000451980BU7 00000412259BU4 00000441126BU0 00000486012BU8 00000492261BU3 00000560228BU9 00000444938BU5 00000548334BU2 00000446439BU2 00000568030BU1 00000558894BU2 00000426862BU9 00000438324BU6 00000450628BU3 00000416642BU7 00000437985BU5 00000442867BU8 00000427980BU8 00000410733BU0 00000433743BU2 00000562980BU3 00000403984BU8 00000486024BU3 00000436759BU5 00000442603BU7 00000563635BU2 00000559112BU8 00000552391BU5 00000498623BU8 00000433946BU1 00000558896BU7 00000458501BU4 00000553275BU9 00000568026BU9 000000006U0009 00000438341BU0 00000497530BU6 00000519391BU7 00000508960BU2 00000425774BU7 00000532542BU8 00000494957BU4 00000529812BU0 00000509834BU8 00000549010BU7 00000416641BU9 00000405303BU9 00000433013BU0 00000427665BU5 00000469682BU9 00000541273BU9 00000543792BU6 00000421893BU9 00000544635BU6 00000549258BU2 00000514043BU9 00000499522BU1 00000484051BU8 00000493728BU0 00000546572BU9 00000401640BU8 00000416591BU6 00000421523BU2 00000565995BU8 00000555780BU6 00000436326BU3 00000448063BU8 00000468307BU4 00000421050BU6 00000557173BU2 00000398531BU4 00000470051BU4 00000463036BU4 00000566791BU0 00000497526BU4 00000444377BU6 00000421107BU4 00000410864BU3 00000450319BU9 00000467397BU6 00000547951BU4 00000437723BU0 00000444937BU7 00000449237BU7 00000432806BU8 00000516951BU1 00000437231BU4 00000416634BU4 00000548834BU1 00000509362BU0 00000436661BU3 00000426709BU2 00000498759BU0 00000457496BU8 00000479709BU8 00000438367BU5 00000421651BU1 00000523135BU2 00000415575BU9 00000493917BU9 00000479227BU1 00000442527BU8 00000466982BU6 00000515952BU0 00000492209BU2 00000437318BU9 00000545958BU1 00000423539BU6 00000428333BU9 00000437988BU9 00000417936BU2 00000441457BU9 00000520406BU0 00000537596BU9 00000447651BU1 00000417964BU4 00000517922BU1 00000548842BU4 00000566833BU0 00000569372BU6 00000560913BU6 00000477278BU6 00000547290BU7 00000559586BU3 00000427224BU1 00000431555BU2 00000544202BU5 00000438350BU1 00000534427BU0 00000521650BU2 00000422738BU5 00000496614BU9 00000467881BU9 00000514611BU3 00000532539BU4 00000515483BU6 00000409754BU9 00000442445BU3 00000416640BU1 00000428061BU6 00000458184BU9 00000436438BU6 00000435786BU9 00000437973BU1 00000554739BU3 00000469690BU2 00000566840BU5 00000551946BU7 00000512763BU4 00000562524BU9 00000420194BU3 00000566593BU0 00000511520BU9 00000441887BU7 00000436762BU9 00000562521BU5 00000442333BU1 00000421379BU9 00000451725BU6 00000430321BU0 00000398532BU2 00000422814BU4 00000411063BU1 00000427988BU1 00000430322BU8 00000544113BU4 00000514612BU1 00000526251BU4 00000398529BU8 00000476681BU2 00000403215BU7 00000556789BU6 00000441270BU6 00000530414BU2 00000493235BU6 00000559582BU2 00000470052BU2 00000417617BU8 and 00000432299BU6.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- United States including Puerto Rico and Guam.
  • Product Description
    GE Innova 4100, 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