Events

Rappel de Innova 4100

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 GE Healthcare, LLC.

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
    56988
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0392-2011
  • Date de mise en oeuvre de l'événement
    2009-08-06
  • Date de publication de l'événement
    2010-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95123
  • 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
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Cause
    Ge healthcare has become aware of a potential video splitter failure with certain innova 2000 and 4100 x-ray systems that may impact patient safety. a potential video splitter failure inside the ge equipment cabinet could occur with no advance warning and thereby prevent x-ray image display. should this occur, the system cannot be recovered without service intervention. ge healthcare has obse.
  • Action
    GE Healthcare sent an " Urgent Medical Device Correction" letter dated July 9, 2009, to Hospital Administrators / Risk mangers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter identified the product, described the Safety Issue, Affected Product Details, Safety Instructions Product correction and Contact Information. Hospitals were instructed to establish emergency workflow procedures should a component stop operating during a patient examination. A GE Healthcare service representative would contact each customer and correct all affected systems. For questions regarding this recall call (262) 548-2731.

Device

Innova 4100
  • Modèle / numéro de série
    00000419171BU4 00000410733BU0 00000421241BU1 00000410864BU3 00000416634BU4 00000411063BU1 00000417936BU2 00000409754BU9 00000416591BU6 00000415816BU8 00000420529BU0 00000415698BU0 00000421391BU4 00000416641BU9 00000409937BU0 00000416642BU7 00000415575BU9 00000420851BU8 00000416960BU3 00000411137BU3 00000408040BU4 00000417375BU3 00000398531BU4 00000417617BU8 00000415776BU4 00000415045BU4 00000403215BU7 00000425774BU7 00000400392BU7 00000418618BU5 00000416643BU5 00000413567BU9 00000415179BU1 00000419079BU9 00000409755BU6 00000412766BU8 00000000LS8-C1 00000425390BU2 00000413716BU2 00000398530BU6 00000405584BU4 00000406451BU5 00000417372BU0
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX UT, VA, WA, WV, and WI, and the countries of UNITED KINGDOM, TUNISIA, TAIWAN, PROVINCE OF CHINA, SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN D=FEDERATION, POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, REPUBLIC OF KOREA, JORDAN, JAPAN, ITALY, IRELAND, ISLAMIC IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE, FINLAND , EGYPT, CHILE, CANADA, BULGARIA, BELGIUM BELARUS, AUSTRALIA.
  • Description du dispositif
    Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) || 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 for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Adresse du fabricant
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA