Events

Recall of Innova 2121IQ / 3131IQ

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-0138-2010
  • 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=82009
  • 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 JAA
  • 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 2121IQ / 3131IQ
  • Model / Serial
    SYSTEM ID:  0847160005 542120XR02  561548BIP  561881BP1  630856H3131 817465AR3131  985867INNOVA31 COR373301 EG1000VA01 LY1086VA01 M4166990  05448VAS01 VAD2121  YE1002VA01 YV0365   NOT LOCOLIZED S/N CHILLER 798080-21 796259-09 794637-08 795371-01 796133-12 796259-05 796464-08 796464-13 796464-15 796767-05 796941-03 796941-04 796941-07 796941-09 797178-05 797179-03 797179-08 797179-12 797449-03 797449-06 797632-02 797812-04 797812-09 797812-10 797812-12 767326-03 770355-02 772153-13 767746-05 785678-16 794637-11 799172-07 799347-03 799347-05 796260-01 783679-01 797178-03 797179-07 797179-09 797179-11 797812-14 797812-16 799347-02 798449-01 798449-02 798449-03
  • 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
    Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
  • 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