Events

Recall of Device Recall Mindray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc. dba Mindray North America.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74758
  • Event Risk Class
    Class 2
  • Event Number
    Z-2689-2016
  • Event Initiated Date
    2016-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148395
  • Notes / Alerts
    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.
  • Extra notes in the data
    Gas-machine, anesthesia - Product Code BSZ
  • Reason
    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
  • Model / Serial
    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.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada
  • Product Description
    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