Events

Rappel de Suinsa FlexiDT Table

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.

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
    44813
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0075-2008
  • Date de mise en oeuvre de l'événement
    2007-08-01
  • Date de publication de l'événement
    2007-11-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64411
  • 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
    Radiolgic Table - Product Code KXJ
  • Cause
    Design problems including: 1) hot brake (longitudinal overheating) potential risk of burns 2) brake locks and sudden releases 3) emergency stop circuit button; open instead of closed 4) longitudinal brakes release does not engage properly 5) tilting movement causing tabletop to slide; may cause risk of pinched fingers to patient and/or operator 6) lodging pins on floor uncovered; may cause potenti.
  • Action
    Recalling firm initiated correction by visit on August 2007. Corrections include replacement of one or more of the following: charger board, pin lodging, rear bumper. Also, replace the interface board and remove resistor mounted on chassis, remove brake pedal and assembly of cosmetic brake or apply caution labels.

Device

Suinsa FlexiDT Table
  • Modèle / numéro de série
    Model # 2269647 / Serial #  00001001025WK4 00001001930WK5 00001002256WK4 00001002566WK6 00001002571WK6 00001003965WK9 00001004156WK4 00001004469WK1 00001007157WK9  Model # 5115763 / Serial#  00000994502WK3 00000997066WK6 00000997612WK7 00000997613WK5 00001000007WK3 00001002479WK2 00001002828WK0 00001003563WK2 00001003571WK5  Model #5128145 / Serial #  00000002041M32 00000002051M31 00001004319WK8 00001005661WK2  Model#5135678 / Serial # 00001004505WK2 00001004507WK8 00001004763WK7 00001004764WK5 00001004771WK0 00001005019WK3 00001005032WK6 00001005033WK4 00001005182WK9 00001005184WK5 00001005260WK3 00001005702WK4 00001005705WK7 00001005707WK3 00001005755WK2 00001005760WK2 00001005762WK8 00001005763WK6 00001005764WK4 00001005911WK1 00001005912WK9 00001006042WK4 00001006179WK4 00001006471WK5 00001006475WK6 00001006478WK0 00001006635WK5 00001006822WK9 00001006873WK2 00001006875WK7 00001006878WK1 00001006880WK7 00001007163WK7 00001007169WK4 00001007191WK8 00001007405WK2 00001007409WK4 00001007478WK9 00001007499WK5 00001007516WK6 00001007528WK1 00001007534WK9 00001007535WK6 00001007649WK5 00001007650WK3 00001007713WK9 00001007717WK0 00001007719WK6 00001007780WK8 00001007782WK4 00001007784WK0 00001007906WK9 00001007910WK1 00001008307WK9 00001008312WK9 00001008682WK5 00001008809WK4 00001008810WK2 00001008835WK9 00001008837WK5 00001008843WK3 00001009057WK9 00001009061WK1 00001009062WK9 00001009063WK7 00001009217WK9 00001009536WK2 00001009604WK8 00001009609WK7 00001009707WK9 00001009817WK6 00001010430WK5  Model #2242088-2 / Serial # 00000001709M35  Model #5141608-2 / Serial # 00000114134VE0
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including States of -- AL, CA, FL, GA, IA, IL, IN, LA, ND, NY, OH, PA, TX, and WI, and Countries of -- BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE, GERMANY, GUAYANA, HONG KONG, HUNGARY, IRELAND, ISRAEL, ITALY, KUWAIT, LATVIA, LEBANON, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.
  • Description du dispositif
    Sunisa Flexi-DT Table, Model Numbers: 51335678, 2269647, 2242088-2, 5141609-2, 5115763, and 5128145, || Manufactured by Suinsa C Primavera, 39 Pol. Ind. Las Monjas, Tarrejon de Ardaz Madrid 28850 Spain
  • Manufacturer
    GE Healthcare

Manufacturer

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