Events

Recall of GE Healthcare Innova

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datex - Ohmeda, Inc.

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
    48977
  • Event Risk Class
    Class 2
  • Event Number
    Z-1519-2008
  • Event Initiated Date
    2006-08-17
  • Event Date Posted
    2008-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72441
  • 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
    Fluoroscopic Imaging System - Product Code MQB
  • Reason
    User was unable to hear the innova 2100-iq 5-minute fluoroscopy warning signal from the table control tssc interface. inability of the user to hear the audible signal indicating the completion of any preset exposure time may lead to incorrect overall dose management, resulting in unnecessary exposure and can be a contributing factor for skin injury. the alarm can be heard in the control room.
  • Action
    GE Field Engineers are visiting all affected customers to apply updated software. For assistance contact Datax-Ohmeda, Inc., at 1-608-221-1551.

Device

GE Healthcare Innova
  • Model / Serial
    serial numbers: 00000007C20050, 00000061993GE2, 00000464046BU2, 00000464088BU4, 00000464127BU0, 00000477752BU0, 00000477766BU0, 00000477779BU3, 00000477793BU4, 00000477807BU2, 00000477808BU0, 00000477816BU3, 00000477827BU0, 00000477833BU8, 00000477840BU3, 00000479549BU8, 00000479577BU9, 00000485033BU5, 00000489690BU8, 00000489717BU9, 00000490496BU7, 00000491059BU2, 00000492423BU9, 00000493965BU8, 00000497494BU5, 00000498674BU1, 00000498692BU3, 00000498707BU9, 00000498882BU0, 00000498888BU7, 00000499681BU5, 00000499701BU1, 00000499702BU9, 00000499711BU0, 00000499720BU1, 00000499728BU4, 00000499936BU3, 00000505083BU6, 00000505109BU9, 00000509176BU4, 00000509205BU1, 00000509236BU6, 00000509237BU4, 00000509242BU4, 00000509243BU2, 00000509246BU5, 00000509252BU3, 00000509253BU1, 00000510040BU9, 00000511613BU2, 00000511672BU8, 00000511684BU3, 00000511685BU0, 00000511692BU6, 00000512738BU6, 00000512755BU5, 00000512825BU1, 00000512826BU9, 00000512829BU3, 00000512831BU9, 00000512834BU3, 00000512840BU0, 00000512866BU5, 00000512884BU8, 00000512889BU7, 00000512890BU5, 00000512897BU0, 00000512905BU1, 00000513093BU5, 00000513107BU3, 00000513112BU3, 00000513128BU9, 00000513172BU7, 00000513175BU0, 00000513183BU4, 00000513184BU2, 00000513189BU1, 00000513205BU5, 00000513267BU5, 00000513277BU4, 00000513278BU2, 00000513523BU1, 00000513527BU2, 00000513536BU3, 00000513544BU7, 00000513548BU8, 00000513549BU6, 00000513551BU2, 00000513570BU2, 00000513571BU0, 00000513576BU9, 00000513589BU2, 00000515118BU8, 00000518728BU1, 00000519107BU7, 00000519126BU7, 00000519153BU1, 00000520046BU4, 00000521647BU8, 00000526236BU5, 00000526308BU2, 00000526309BU0, 00000526348BU8, 00000526382BU7, 00000526383BU5, 00000526384BU3, 00000526386BU8, 00000526559BU0, 00000528646BU3, 00000529467BU3, 00000529510BU0, 00000529664BU5, 00000529681BU9, 00000530226BU0, 00000534470BU0, 00000534725BU7, 00000538734BU5, 00000538740BU2, 00000543268BU7, 00000545045BU7, 00000545590BU2, 00000546170BU2, 00000546434BU2, 00000546573BU7, 00000547027BU3, 00000547211BU3, 00000549174BU1, 00000772852-02, 00002UA6251HCZ, 00002UA6420FDN. systems id: 2667313, 82416040018, 82416130018.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Algeria, Australia, Belgium, Brazil, Canada, China, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Malaysia, Mexico, New Zealand, Norway, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Syria, Taiwan, Turkey, and United Kingdom
  • Product Description
    GE Healthcare Innova 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular imaging system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.
  • Manufacturer
    Datex - Ohmeda, Inc

Manufacturer

Datex - Ohmeda, Inc
  • Manufacturer Address
    Datex - Ohmeda, Inc, Po Box 7550, Madison WI 53707
  • Source
    USFDA