Events

Rappel de GE Healthcare Innova

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Datex - Ohmeda, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    48977
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1518-2008
  • Date de mise en oeuvre de l'événement
    2006-08-17
  • Date de publication de l'événement
    2008-09-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-06-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72439
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Fluoroscopic Imaging System - Product Code MQB
  • Cause
    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
  • Modèle / numéro de série
    serial numbers: 00000007C20041, 00000046457BU0, 00000046582BU1, 00000051324BU5, 000000MI000555, 00000454582BU8, 00000455797BU9, 00000459650BU8, 00000459651BU6, 00000459652BU4, 00000459653BU2, 00000459654BU0, 00000459655BU7, 00000459656BU5, 00000459657BU3, 00000459658BU1, 00000459659BU9, 00000459661BU5, 00000459663BU1, 00000459664BU9, 00000459665BU6, 00000459667BU2, 00000459668BU0, 00000459669BU8, 00000459670BU6, 00000459672BU2, 00000459673BU0, 00000459674BU8, 00000459675BU5, 00000459676BU3, 00000459677BU1, 00000459891BU8, 00000464564BU4, 00000464565BU1, 00000464566BU9, 00000464567BU7, 00000464568BU5, 00000464570BU1, 00000464571BU9, 00000464572BU7, 00000464573BU5, 00000464574BU3, 00000464576BU8, 00000464577BU6, 00000464578BU4, 00000464579BU2, 00000464580BU0, 00000464581BU8, 00000464582BU6, 00000464585BU9, 00000464586BU7, 00000464587BU5, 00000464588BU3, 00000464589BU1, 00000464590BU9, 00000464591BU7, 00000464592BU5, 00000464593BU3, 00000465560BU1, 00000465794BU6, 00000465795BU3, 00000465796BU1, 00000465821BU7, 00000465822BU5, 00000465823BU3, 00000465825BU8, 00000465827BU4, 00000465828BU2, 00000465829BU0, 00000465830BU8, 00000465831BU6, 00000465832BU4, 00000465834BU0, 00000465835BU7, 00000465836BU5, 00000465837BU3, 00000465838BU1, 00000465839BU9, 00000465840BU7, 00000465841BU5, 00000465842BU3, 00000465843BU1, 00000465845BU6, 00000465846BU4, 00000465848BU0, 00000465849BU8, 00000466836BU4, 00000466838BU0, 00000466839BU8, 00000466841BU4, 00000466843BU0, 00000466844BU8, 00000466845BU5, 00000466846BU3, 00000466847BU1, 00000466848BU9, 00000466849BU7, 00000466850BU5, 00000466851BU3, 00000466852BU1, 00000466853BU9, 00000466856BU2, 00000466857BU0, 00000466859BU6, 00000466860BU4, 00000466861BU2, 00000466862BU0, 00000466863BU8, 00000466864BU6, 00000466865BU3, 00000478319BU7, 00000478320BU5, 00000478323BU9, 00000478324BU7, 00000478326BU2, 00000478327BU0, 00000478328BU8, 00000478330BU4, 00000478331BU2, 00000478333BU8, 00000478337BU9, 00000478338BU7, 00000478339BU5, 00000478340BU3, 00000478341BU1, 00000478342BU9, 00000478345BU2, 00000478346BU0, 00000478347BU8, 00000478348BU6, 00000485080BU6, 00000489536BU3, 00000489537BU1, 00000489538BU9, 00000489539BU7, 00000489540BU5, 00000489542BU1, 00000489543BU9, 00000489544BU7, 00000489546BU2, 00000489547BU0, 00000489548BU8, 00000489549BU6, 00000489551BU2, 00000489553BU8, 00000489555BU3, 00000489557BU9, 00000489558BU7, 00000489561BU1, 00000489562BU9, 00000489564BU5, 00000489565BU2, 00000489683BU3, 00000489684BU1, 00000489688BU2, 00000489738BU5, 00000489744BU3, 00000489747BU6, 00000489753BU4, 00000489756BU7, 00000489757BU5, 00000489761BU7, 00000489763BU3, 00000489770BU8, 00000489772BU4, 00000498661BU8, 00000498679BU0, 00000498710BU3, 00000498711BU1, 00000498712BU9, 00000498713BU7, 00000498715BU2, 00000498717BU8, 00000498718BU6, 00000498719BU4, 00000498720BU2, 00000498721BU0, 00000498722BU8, 00000498723BU6, 00000508755BU6, 00000509439BU6, 00000512697BU4, 00000512701BU4, 00000512713BU9, 00000512715BU4, 00000512727BU9, 00000512818BU6, 00000512819BU4, 00000512821BU0, 00000512822BU8, 00000512823BU6, 00000512828BU5, 00000512868BU1, 00000512870BU7, 00000512871BU5, 00000512874BU9, 00000512875BU6, 00000512877BU2, 00000512880BU6, 00000512883BU0, 00000512888BU9, 00000512891BU3, 00000512892BU1, 00000512894BU7, 00000512898BU8, 00000513110BU7, 00000513118BU0, 00000513161BU0, 00000513190BU9, 00000513204BU8, 00000513206BU3, 00000513207BU1, 00000513208BU9, 00000513209BU7, 00000513212BU1, 00000513244BU4, 00000513265BU9, 00000513274BU1, 00000513296BU4, 00000513516BU5, 00000513533BU0, 00000513539BU7, 00000513541BU3, 00000513547BU0, 00000513555BU3, 00000513558BU7, 00000513560BU3, 00000513567BU8, 00000519094BU7, 00000519100BU2, 00000519106BU9, 00000519109BU3, 00000519121BU8, 00000519125BU9, 00000519129BU1, 00000519131BU7, 00000520045BU6, 00000520048BU0, 00000520050BU6, 00000520065BU4, 00000520070BU4, 00000520075BU3, 00000520083BU7, 00000526275BU3, 00000526389BU2, 00000526556BU6, 00000526557BU4, 00000526560BU8, 00000526562BU4, 00000526563BU2, 00000526648BU1, 00000526681BU2, 00000529461BU6, 00000530106BU4, 00000530116BU3, 00000530120BU5, 00000530242BU7, 00000530246BU8, 00000530248BU4, 00000530410BU0, 00000530413BU4, 00000536802BU2, 00000538053BU0, 00000543790BU0, 00000544289BU2, 00000545052BU3, 00000546574BU5, 00000547017BU4. systems id: 835160017, 82416070006, 00192VAS05, 214947MINNOVA2, 305682IN2X, 318448INNOVA3, 83INNOVA2588441, B5219603, H0002VAS66, HU1099VA02, RPINNOVA2100, YV0053.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular 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
  • Adresse du fabricant
    Datex - Ohmeda, Inc, Po Box 7550, Madison WI 53707
  • Source
    USFDA