Events

Recall of Device Recall GE Healthcare Innova

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
    37775
  • Event Risk Class
    Class 2
  • Event Number
    Z-0915-2007
  • Event Initiated Date
    2007-02-05
  • Event Date Posted
    2007-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51506
  • 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 - Product Code MQB
  • Reason
    Unintended gantry movements : ge healthcare has recently become aware of accidental, operated-initiated activation of gantry movements associated with the new, metallic smart box controller that may impact patient or staff safely.
  • Action
    Consignees were contacted via a letter "Urgent: Safety Notice" dated 2/5/07. The letter described the safety issue, affected product, safety instructions and product correction contact information. -This is the short-term fix, GE is working on a correction that will be installed at each site as the long term correction

Device

Device Recall GE Healthcare Innova
  • Model / Serial
    5135844100 5136864100 314569SJRM12 530888ANG206 713375U4100 804320CATH2B 804764CATH3 812238UN41 812238UN41 813615CL10 843577CL2 972566INNOVA3 80140841 3016094100 3027444100 4134474100 5033704100 5094744100 5417684100 6309784100 7028804100 201541SP1 251435I12 252847PRS3 309672M4100 330489SPEC9 360754INNOVA 386HPOS1 412623LAB1 412623LAB3 414328INN4100 419696LAB1 509482HFI 605333RM10 608263XMR 610954INNOVA41 617525IN1 617636IN1 630275G41 678EJCIR1 719560INN41 727791INNOVA 770535N4100 803256SP 804594ANGIO 816943SP1 817433HSW4100 845368RM10 904202SP1 904BSSP 908522SP1 915577SP1 918682IN41 952993INNOVA2 970247INNOVA 972335LIB COR359867 00171VAS01 00490VAS02 10091VAS01 190020RX09 600152VA01 A5605732 BRD0411 IE1100VA01 IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 850060707 850060722 082406120016 082416130020 XF0154 XF0155 XF0200 306766INNOVA 519663INNOVA2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including states of WV, WI, WA, VA, UT, TX, TN, SD, SC, PA, OR, OK,OH, NY, NV, NJ, NE, NC, MT, MO, MN, MI, ME, MD, MA, LA, KY, KS, IN, IL, ID, HI, GU, GA, FL, DE, CT, CO, CA, AZ, AL, AK and countries of UNITED KINGDOM, TURKEY, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SAUDI ARABIA, RUSSIA, POLAND, NORWAY, NEW ZEALAND, THE NETHERLANDS, MOROCCO, MALAYSIA, KOREA, JORDAN, JAPAN, ITALY, ISREAL, IRELAND, INDIA, HUNGARY, GREECE, GERMANY, FRANCE, FINLAND , DENMARK, CZECH REPUBLIC, CHINA, CANADA, BELGIUM, AUSTRALIA, and ALGERIA.
  • Product Description
    GE Healthcare Innova 4100/ 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography 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