Events

Recall of Device Recall GE Healthcare Innova 3100/ 3100 IQ

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by General Electric Med Systems 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
    37723
  • Event Risk Class
    Class 2
  • Event Number
    Z-0870-2007
  • Event Initiated Date
    2007-03-26
  • Event Date Posted
    2007-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51382
  • 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
    Digital Fluoroscopic Imaging System - Product Code MQB
  • Reason
    Measurement errors during the computation of vessel diameters while using the stenosis analysis software (also known as quantitative coronary analysis function-qca) using the auto-calibration function on innova digital (located in control room) or in-room innovacentral/touch-screen.
  • Action
    A letter dated Jan. 18, 2007, was sent to consignees describing the problem, product ,safety instructions and contact information. Software upgrades were promised for correction.

Device

Device Recall GE Healthcare Innova 3100/ 3100 IQ
  • Model / Serial
    3027443100 7022333100 082416030003 082416040015 082416040019 082416120007 082416120010 082416160008 082416210006 082416220008 082449120007 214590PH3100 303425CL4 405272SCL2 405840OIC3100 412623LAB2 414647CL1 415925INV1 480728LAB2 516562INNOVA8 573882UMC1 717782INNOVA31A 718470INNOVA2 816943STJIC1 816985NKCI 918494IN31A 920169007 A5162256 A5333035 CS1006VA03 FI1064VA01 M40480151 M4163030 YV0027 YV0028 YV0029 YV0034 YV0035 YV0037
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA states including-AZ,CA,CO,DE,FL,GA,IL,IN, MD,MN,MO,NJ,NV,NY,OH,OK,OR,PA,SC,SD,TX, UT, VA,WA,WI, and countries of Canada, Belgium, China, Czech Republic, Finland, France, Germany, Hungary, India, Isreal, Italy, Japan, Korea, New Zealand, Norway, Russia, Spain, and United Kingdom.
  • Product Description
    GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)
  • Manufacturer
    General Electric Med Systems LLC

Manufacturer

General Electric Med Systems LLC
  • Manufacturer Address
    General Electric Med Systems LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Source
    USFDA