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U.S. Department of Health and Human Services

Class 2 Device Recall Mindray

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  Class 2 Device Recall Mindray see related information
Date Initiated by Firm June 15, 2016
Create Date August 30, 2016
Recall Status1 Terminated 3 on March 28, 2017
Recall Number Z-2689-2016
Recall Event ID 74758
510(K)Number K151954  
Product Classification Gas-machine, anesthesia - Product Code BSZ
Product 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)
Code Information 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.
Recalling Firm/
Manufacturer		 Mindray DS USA, Inc. dba Mindray North America
800 Macarthur Blvd
Mahwah NJ 07430-2001
For Additional Information Contact Ms. Diane Arpino
201-995-8407
Manufacturer Reason
for Recall		 Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System.
FDA Determined
Cause 2		 Nonconforming Material/Component
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
Quantity in Commerce 167 units (165 units - US) and (2 units - International)
Distribution US Nationwide Distribution to AL, MA, MD, MN, MO, NE, NJ, OK, OR, PA and VA; and Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
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