Events

Rappel de Device Recall Mindray

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 Mindray DS USA, Inc. dba Mindray North America.

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
    74758
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2689-2016
  • Date de mise en oeuvre de l'événement
    2016-06-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148395
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Cause
    Potential for a leak to occur on the back-up o2 and air e-size cylinder yokes on the a7 anesthesia delivery system.
  • Action
    Mindray sent via certified mail with return receipt a recall letter dated June 15, 2016 to their affected customers. Mindray will replace the gasket on all e-size cylinder yokes on the affected A7 systems. Customer was instructed to contact their local Mindray Service Representative to arrange for this replacement. Customers can continue to use their A7 system while awaiting the replacement of the gasket(s). Customers can contact Ms. Diane Arpino, Director, Quality Operations and Regulatory Affairs via email to: d.arpino@mindray.com or via telephone to: (201)995-8407

Device

Device Recall Mindray
  • Modèle / numéro de série
    P/N 0632F-PA0000X - (Domestic) and 0632B-PA00014 - (International)   Serial numbers FR-5B000341, FR-5B000342, FR-5B000343, FR-5B000348, FR-5B000349, FR-51000148, FR-51000149, FR-51000150, FR-51000151, FR-51000152, FR-51000153, FR-51000154, FR-51000159 , FR-51000161, FR-51000162, FR-51000163, FR-51000164, FR-51000165, FR-51000166, FR-51000167, FR-51000168, FR-51000170, FR-51000171, FR-52000172, FR-52000173, FR-52000175, FR-52000176, FR-52000177, FR-52000178, FR-52000180, FR-52000181, FR-52000182, FR-52000183, FR-52000184, FR-52000185, FR-52000186, FR-53000187, FR-53000188, FR-53000189, FR-53000190, FR-53000191, FR-53000192, FR-53000193, FR-53000194, FR-53000197, FR-53000198, FR-53000199, FR-53000200, FR-53000203, FR-53000205, FR-53000206, FR-53000207, FR-53000209, FR-53000211, FR-53000212, FR-53000213, FR-53000214, FR-53000215, FR-53000216, FR-53000217, FR-54000218, FR-54000220, FR-54000221, FR-54000223, FR-54000224, FR-54000228, FR-54000229, FR-54000231, FR-54000233, FR-54000234, FR-54000235, FR-54000236, FR-54000237, FR-54000238, FR-54000239, FR-54000240, FR-54000241, FR-54000242, FR-54000243, FR-54000244, FR-56000245, FR-56000246, FR-56000247, FR-56000248, FR-56000249, FR-56000250, FR-56000251, FR-56000252, FR-56000253, FR-56000254, FR-56000255, FR-56000256, FR-56000257, FR-56000258, FR-56000259, FR-56000260, FR-56000261, FR-56000262, FR-56000265, FR-56000266, FR-56000267, FR-56000268, FR-57000269, FR-57000270, FR-57000271, FR-57000272, FR-57000274, FR-57000275, FR-57000276, FR-57000277, FR-57000278, FR-57000279, FR-57000280, FR-57000281, FR-57000282, FR-57000283, FR-57000284, FR-57000285, FR-57000286, FR-57000287, FR-57000288, FR-58000289, FR-58000290, FR-58000291, FR-58000292, FR-58000293, FR-58000294, FR-58000295, FR-58000296, FR-58000297, FR-58000298, FR-58000299, FR-58000300, FR-58000301, FR-58000302, FR-58000303, FR-58000304, FR-58000305, FR-58000306, FR-58000307, FR-58000308, FR-58000312, FR-58000313, FR-58000314, FR-58000315, FR-58000316, FR-58000317, FR-58000318, FR-58000319, FR-58000320, FR-58000321, FR-58000322, FR-58000323, FR-58000325, FR-59000330, FR-59000331, FR-59000333, FR-59000334, FR-59000335, FR-59000336, FR-59000338, and FR-59000339.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada
  • Description du dispositif
    A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)
  • Manufacturer
    Mindray DS USA, Inc. dba Mindray North America

Manufacturer

Mindray DS USA, Inc. dba Mindray North America