Events

Recall of Innova 4100 / 4100 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-0137-2010
  • 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=82008
  • 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 IYO
  • 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 4100 / 4100 IQ
  • Model / Serial
    SYSTEM ID:  80158241 06014VAS01 06063VAS01 082406100018 0828160011 205759CL2  207662OR4100 215662INNOVA1  216844INNOVA  228809VASC  22925941V2  309672M4100 414649DVI 508383IN4100 509575YM4100  6012884100SUR  715369INN4100 718518CVL1  801268INNOVA 812825INNOVA1 843789SP1  865373SP 865541CCL5  904BSSP  910907WAVAS1  9408984100 A56364110 BG4037XR01 HC1819XR09 HC2001XR02 M2030711  NO1017VA03 NO1064VA04 RU2526VA01 XF0160
  • 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 4100 / 4100 IQ. , ( 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