Events

Recall of Innova 2100 IQ

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical 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
    52056
  • Event Risk Class
    Class 2
  • Event Number
    Z-0136-2010
  • Event Initiated Date
    2009-04-16
  • Event Date Posted
    2009-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82007
  • 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
    Cardiovascular Imaging System - Product Code IZI
  • Reason
    Potential pump failure associated with the coolix 4000 chiller of the innova single plane and biplane systems that may stop the chiller from working. if a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the x-ray is inhibited. this could lead to a delay in treatment and possible additional x-ray exposure and contra.
  • Action
    Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.

Device

Innova 2100 IQ
  • Model / Serial
    SYSTEM ID:  850060731 853060205 82416020006 82416090003 82416120015 82416120016 82416210014 83016022101218 83016842101519 0002780363 00052VAS04  00052VAS05  00060VAS03  010120RX44 082416030012 082416130029 083016002001498 083016802101749 083016822101709 083016862101268 0910064010 110019RX13  1299563 17005VAS01  304526INNOVA  318449INNOVA3  407321INCL2  410368INNOVA1  503561CL1  503561CL4  526354XR13 573815BCR3  603882CATH1  609757IN2100  706774HT4 717217INN21 717544GECATH2  732776CATH4 732923INN 816347SLE2100 816861KCVAI2 816861KCVAI2  818INNOVAHMS1  828315FEP  910343NHIN3  A5152993 A5330714 B5483438 BG4033VA01 C5123626  GOLD010016 HR4106VA01 HR4107VA01 HU1173VA03 LV4000VA04 M4183841 M4484974 RO1180VA01 RU3301VA01 YV0562
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.
  • Product Description
    GE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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