Z-2689-2016Class II

A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a...

Name: Z-2689-2016 A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2016-06-15
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2016-06-15 / Terminated / root cause: manufacturing process

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a... on 2016-06-15. FDA classified it as Class II and gives the reason as "Potential for a leak to occur on the back-up O2 and air e-size cylinder yokes on the A7 Anesthesia Delivery System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2689-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-15
Posted: 2016-08-30
Terminated: 2017-03-28
Recalling firm: Datascope Corp.
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)
Product code: BSZ Gas-Machine, Anesthesia
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.
Root cause tag: manufacturing process
FDA root cause: 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: [email protected] 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2689-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2689-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-30

Product code BSZ

K151954Class IIA7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2015-10-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)