Events

Rappel de Device Recall Nuclear Magnetic Resonance Imaging System

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 Medical Systems, 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
    51314
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1723-2009
  • Date de mise en oeuvre de l'événement
    2008-11-03
  • Date de publication de l'événement
    2009-08-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80290
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Cause
    Ge healthcare has identified a potential pinch point hazard on ovation mr scanner when using ctl array xl body flex and opened body coil. a patient's hand may be pinched between the magnet bore ceiling cover and the ctl array, xl body flex, or open body coil if the patient puts his/her hand on the top of the coil. two injuries and four complaints filed. 2/20/09: recall being expanded to incl.
  • Action
    GE Healthcare issued a "Product Safety Notification" letter dated October 23, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology/Cardiology & Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product, Safety Instructions, Product Correction and Contact Information for the Signa Ovation 0.35T Systems. A second GE Healthcare "Urgent Medical Device Correction" letter dated March 5, 2009 was sent 3/9/09 to consignees which addressed the expanded recall to the Signa OpenSpeed0.7T MR Systems. For further questions, contact your local GE Healthcare sales or service representative.

Device

Device Recall Nuclear Magnetic Resonance Imaging System
  • Modèle / numéro de série
    Model Number: 2138300-30;  Serial Numbers: 00000203387MR6, 00000208208MR9, 00000216409MR3, 00000229302MR5, 00000229306MR6, 00000230309MR7, 00000231588MR5, 00000237930MR3, 00000239847MR7, 00000241694MR9, 00000247255MR3, 00000253103MR6, 00000189633MR1, 00000192104MR8, 00000193652MR5, 00000194218MR4, 00000194219MR2, 00000194950MR2, 00000196364MR4, 00000197334MR6, 00000198709MR8, 00000199443MR3, 00000201708MR5, 00000201709MR3, 00000201710MR1, 00000201901MR6, 00000202223MR4, 00000203386MR8, 00000204837MR9, 00000204838MR7, 00000204839MR5, 00000206438MR4, 00000206439MR2, 00000207493MR8, 00000207494MR6, 00000208209MR7, 00000208210MR5, 00000209712MR9, 00000209713MR7, 00000212511MR0, 00000212513MR6, 00000212514MR4, 00000212515MR1, 00000215366MR6, 00000216405MR1, 00000216406MR9, 00000216407MR7, 00000216409MR3, 00000217198MR1, 00000217201MR3, 00000221250MR4, 00000221251MR2, 00000221253MR8, 00000221254MR6, 00000222950MR8, 00000225273MR2, 00000225274MR0, 00000225942MR2, 00000226318MR4, 00000228022MR0, 00000228023MR8, 00000228024MR6, 00000228773MR8, 00000229303MR3, 00000229304MR1, 00000229305MR8, 00000230308MR9, 00000230312MR1, 00000231591MR9, 00000231592MR7, 00000232328MR5, 00000233644MR4, 00000233646MR9, 00000234832MR4, 00000234833MR2, 00000234834MR0, 00000237051MR8, 00000237052MR6, 00000237053MR4, 00000237926MR1, 00000237927MR9, 00000237928MR7, 00000237929MR5, 00000239480MR7, 00000239482MR3, 00000239483MR1, 00000239484MR9, 00000239845MR1, 00000239846MR9, 00000241126MR2, 00000241127MR0, 00000241693MR1, 00000241695MR6, 00000243405MR8, 00000244231MR7, 00000244232MR5, 00000247252MR0, 00000247253MR8, 00000247254MR6, 00000247256MR1, 00000250184MR9, 00000250185MR6, 00000250186MR4, 00000250187MR2, 00000253039MR2, 00000253102MR8, Unknown;  Model Number: 2377062-5;  Serial Numbers: 00000000100YR8, 00000000119YR8, 00000000129YR7, 00000000102YR4, 00000000103YR2, 00000000105YR7, 00000000106YR5, 00000000108YR1, 00000000109YR9, 00000000111YR5, 00000000113YR1, 00000000118YR0, 00000000120YR6, 00000000122YR2, 00000000124YR8, 00000000127YR1, 00000000128YR9, 00000000131YR3, 00000000132YR1, 00000000133YR9, 00000000134YR7, 00000000135YR4, 00000000136YR2, 00000000137YR0, 00000000142YR0, 00000000144YR6, 00000000146YR1, 00000000149YR5, 00000000150YR3, 00000000151YR1, 00000000152YR9, 00000000155YR2, 00000943610YM6, 00000951021YM5, 00000962592YM2;  Model Number: 2377062-30  Serial Numbers: 00000003047YR8, 00000003011YR4, 00000003022YR1, 00000003023YR9, 00000003024YR7, 00000003025YR4, 00000003026YR2, 00000003027YR0, 00000003028YR8, 00000003029YR6, 00000003030YR4, 00000003031YR2, 00000003033YR8, 00000003034YR6, 00000003035YR3, 00000003036YR1, 00000003039YR5, 00000003041YR1, 00000003042YR9, 00000003043YR7 and 00000003044YR5.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- US (including states of AL, ALZ, AR, CA, CO,CT, DE, FL, FA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MT, MO, NE,NH, NV, NJ, NY, NC, OH, OK, OR, PA, PR, SC SD, TN, TX, VA, WA, WV and WI), CHINA, CYPRUS, ARGENTINA, BRAZIL EGYPT, DENMARK, FEDERAL REPUBLIC OF GERMANY, FEDERAL REPUBLIC OF FRANCE, GET 7 D CHINA, GREECE, HUNGARY, ITALY, IVORY COAST, JAPAN, KOREA, KUWAIT, MALAWI, MEXICO, OMAN, PANAMA, PHILIPPINES, RUSSIAN FEDERATION, SAUDI ARABIA, SPAIN , SWITZERLAND, TURKEY, UKRAINE, UNITED ARAB EMERITUS, UNITED KINGDOM and VENEZUELA.
  • Description du dispositif
    Signa Openspeed 0.7T MR Systems, Model Numbers: || Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30)
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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