Events

Rappel de Device Recall UniCircuit (W Connector, Adaptor, Y piece)

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
    52605
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1870-2009
  • Date de mise en oeuvre de l'événement
    2009-06-05
  • Date de publication de l'événement
    2009-09-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83446
  • 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
    Breathing circuit - Product Code CAI
  • Cause
    Breathing circuit inner tube may separate from the rigid connectors under certain conditions. a separation of the inner tube from the connector may prevent adequate gas flow (o2, n2o and anesthetic agents) to the patient. a separation can also cause co2 re-breathing. this could lead to hypoxia and/or hypercarbia and inadequate anesthesia delivery.
  • Action
    GE Healthcare sent consignees 6/5/09 an "Urgent Medical Device Correction" letter dated June 5, 2009. The letter was addressed to Health Care Administrator/Risk Manager; Chief of Anesthesia; Director of Clinical Engineering; Risk Manager. The letter described the Safety Issue, Affected Product Details, Safety Instructions (included "Recall Confirmation" form fax to 973-790-4150), Product Correction and Contact Information.

Device

Device Recall UniCircuit (W Connector, Adaptor, Y piece)
  • Modèle / numéro de série
    This correction pertains to Uni-Circuits from lot# 084812 and later, up to and including lot# 092210
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, AUSTRALIA, DENMARK, FRANCE, ESTONIA, GERMANY, ITALY, JORDAN, NETHERLANDS, NORWAY, SWEDEN, and UNITED ARAB EMIRATES.
  • Description du dispositif
    GE Healthcare, Uni-Circuit Kit, Adult, Disposable, 1.8 m/72 in, REF M1089028, M1087972, M1087975, M1126445, M1127508, M1127509, M1129780, || M1129781, M1130230, M1137805, M1137199, M1145542, M1170604, M1151662, || M1152224, M1158990, M1100486, M1122080, M1126444, M1163003, M1163255 || M1132533, M1133966, M1170051, M1135144, M1139485, M1118627, M1118628, || M1145406, M1147298, M1137811, M1152651, M1160275. pkg of 20 pcs, Latex Free. Breathing circuit for use with anesthesia machine or ventilator.
  • 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