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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare DatexOhmeda Aisys

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  Class 2 Device Recall GE Healthcare DatexOhmeda Aisys see related information
Date Initiated by Firm August 10, 2006
Date Posted November 07, 2006
Recall Status1 Terminated 3 on February 24, 2008
Recall Number Z-0021-2007
Recall Event ID 36057
510(K)Number K061609  
Product Classification Anesthesia Delivery System - Product Code BSZ
Product GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company
Code Information Serial numbers: ANAK00115, ANAH00114, ANAH00115, ANAH00116, ANAH00117, ANAH00124, ANAH00126, ANAJ00100, ANAJ00101, ANAJ00102, ANAJ00103, ANAJ00104, ANAJ00105, ANAJ00106, ANAJ00107, ANAJ00108, ANAJ00109, ANAJ00110, ANAJ00111, ANAJ00112, ANAJ00113, ANAJ00114, ANAJ00115, ANAJ00116, ANAJ00117, ANAJ00118, ANAJ00119, ANAJ00120, ANAJ00121, ANAJ00122, ANAJ00123, ANAJ00124, ANAJ00125, ANAJ00126, ANAJ00127, ANAJ00128, ANAJ00129, ANAJ00131, ANAJ00132, ANAJ00133, ANAJ00134, ANAJ00135, ANAJ00136, ANAJ00137, ANAJ00138, ANAJ00139, ANAJ00140, ANAJ00141, ANAJ00142, ANAJ00143, ANAJ00144, ANAJ00145, ANAJ00146, ANAJ00147, ANAJ00148, ANAJ00149, ANAJ00150, ANAJ00151, ANAJ00152, ANAJ00153, ANAJ00154, ANAJ00155, ANAJ00156, ANAJ00157, ANAJ00158, ANAJ00159, ANAJ00160, ANAJ00161, ANAJ00162, ANAJ00163, ANAJ00164, ANAJ00165, ANAJ00166, ANAJ00167, ANAJ00168, ANAJ00169, ANAJ00170, ANAJ00171, ANAJ00172, ANAJ00173, ANAJ00174, ANAJ00175, ANAJ00176, ANAJ00177, ANAJ00178, ANAJ00179, ANAJ00180, ANAJ00181, ANAJ00182, ANAJ00183, ANAJ00184, ANAJ00185, ANAJ00186, ANAJ00187, ANAJ00188, ANAJ00189, ANAJ00190, ANAJ00191, ANAJ00192, ANAJ00193, ANAJ00194, ANAJ00195, ANAJ00195, ANAJ00196, ANAJ00197, ANAJ00198, ANAJ00199, ANAJ00200, ANAJ00201, ANAJ00202, ANAJ00203, ANAJ00204, ANAJ00205, ANAJ00206, ANAJ00207, ANAJ00208, ANAJ00209, ANAJ00210, ANAJ00211, ANAJ00212, ANAJ00213, ANAJ00214, ANAJ00215, ANAJ00216, ANAJ00217, ANAJ00218, ANAJ00219, ANAJ00220, ANAJ00221, ANAJ00222, ANAJ00223, ANAJ00224, ANAJ00225, ANAJ00226, ANAJ00227, ANAJ00228, ANAJ00229, ANAJ00230, ANAJ00231, ANAJ00232, ANAJ00233, ANAJ00234, ANAJ00235, ANAJ00236, ANAJ00237, ANAJ00238, ANAJ00239, ANAJ00240, ANAJ00241, ANAJ00242, ANAJ00243, ANAJ00244, ANAJ00245, ANAJ00246, ANAJ00247, ANAJ00248, ANAJ00249, ANAJ00250, ANAJ00251, ANAJ00252, ANAJ00253, ANAJ00254, ANAJ00255, ANAJ00256, ANAJ00257, ANAJ00258, ANAJ00259, ANAJ00260, ANAJ00261, ANAJ00262, ANAJ00263, ANAJ00264, ANAJ00265, ANAJ00266, ANAJ00267, ANAK00100, ANAK00101, ANAK00102, ANAK00103, ANAK00104, ANAK00105, ANAK00106, ANAK00107, ANAK00108, ANAK00109, ANAK00110, ANAK00111, ANAK00112, ANAK00113, ANAK00114, ANAK00116, ANAK00117, ANAK00118, ANAK00119, ANAK00120, ANAK00121, ANAK00122, ANAK00123, ANAK00124, ANAK00125, ANAK00126, ANAK00127, ANAK00128, ANAK00129, ANAK00130, ANAK00131, ANAK00132, ANAK00133, ANAK00134, ANAK00135, ANAK00136, ANAK00137, ANAK00138, ANAK00139, ANAK00140, ANAK00141, ANAK00142, ANAK00143, ANAK00144, ANAK00145, ANAK00146, ANAK00147, ANAK00148, ANAK00149, ANAK00150, ANAK00151, ANAK00152, ANAK00153, ANAK00154, ANAK00155, ANAK00156, ANAK00156, ANAK00157, ANAK00158, ANAK00159, ANAK00160, ANAK00161, ANAK00162, ANAK00163, ANAK00164, ANAK00165, ANAK00166, ANAK00167, ANAK00168, ANAK00169, ANAK00170, ANAK00171, ANAK00172, ANAK00173, ANAK00174, ANAK00175, ANAK00176, ANAK00177, ANAK00178, ANAK00179, ANAK00180, ANAK00181, ANAK00182, ANAK00183, ANAK00184, ANAK00185, ANAK00186, ANAK00187, ANAK00188, ANAK00189, ANAK00190, ANAK00191, ANAK00192, ANAK00193, ANAK00194, ANAK00195, ANAK00196, ANAK00197, ANAK00198, ANAK00199, ANAK00200, ANAK00201, ANAK00202, ANAK00203, ANAK00204, ANAK00205, ANAK00206, ANAK00207, ANAK00208, ANAK00209, ANAK00210, ANAK00211, ANAK00212, ANAK00213, ANAK00214, ANAK00215, ANAK00216, ANAK00217, ANAK00218, ANAK00219, ANAK00220, ANAK00221, ANAK00222, ANAK00223, ANAK00224, ANAK00225, ANAK00226, ANAK00227, ANAK00228, ANAK00229, ANAK00230, ANAK00231, ANAK00232, ANAK00233, ANAK00234, ANAK00235, ANAK00236, ANAK00237, ANAK00238, ANAK00239, ANAK00240, ANAK00241, ANAK00242, ANAK00243, ANAK00244, ANAK00245, ANAK00246, ANAK00247, ANAK00248, ANAK00249, ANAK00250, ANAK00251, ANAK00252, ANAK00253, ANAK00254, ANAK00255, ANAK00256, ANAK00257, ANAK00258, ANAK00259, ANAK00260, ANAK00261, ANAK00262, ANAK00263, ANAK00264, ANAK00265, ANAK00266, ANAK00267, ANAK00268, ANAK00269, ANAK00270, ANAK00271, ANAK00272, ANAK00273, ANAK00274, ANAK00275, ANAK00276, ANAK00277, ANAK00278, ANAK00279, ANAK00280, ANAK00281, ANAK00282, ANAK00283, ANAK00284, ANAK00285, ANAK00286, ANAK00287, ANAK00288, ANAK00289, ANAK00290, ANAK00291, ANAK00292, ANAK00293, ANAK00294, ANAK00295, ANAK00296, ANAK00297, ANAK00298, ANAK00299, ANAK00300, ANAK00301, ANAK00302, ANAK00303, ANAK00304, ANAK00305, ANAK00306, ANAK00307, ANAK00308, ANAK00309, ANAK00310, ANAK00311, ANAK00312, ANAK00313, ANAK00314, ANAK00315, ANAK00316, ANAK00317, ANAK00318, ANAK00319, ANAK00320, ANAK00321, ANAK00322, ANAK00323, ANAK00324, ANAK00325, ANAK00326, ANAK00327, ANAK00329, ANAK00330, ANAK00331, ANAK00332, ANAK00333, ANAK00334, ANAK00335, ANAK00336, ANAK00337, ANAK00338, ANAK00339, ANAK00340, ANAK00341, ANAK00342, ANAK00343, ANAK00344, ANAK00348, ANAK00349, ANAK00350, ANAK00351, ANAK00352, ANAK00353, ANAK00354, ANAK00355, ANAK00356, ANAK00357, ANAK00358, ANAK00359, ANAK00360, ANAK00361, ANAK00362, ANAK00363, ANAK00364, ANAK00365, ANAK00366, ANAK00367, ANAK00368, ANAK00369, ANAK00370, ANAK00371, ANAK00372, ANAK00373, ANAK00374, ANAK00375, ANAK00376, ANAK00377, ANAK00378, ANAK00379, ANAK00380, ANAK00381, ANAK00382, ANAK00383, ANAK00384, ANAK00385, ANAK00386, ANAK00387, ANAK00388, ANAK00389, ANAK00390, ANAK00391, ANAK00392, ANAK00393, ANAK00394, ANAK00395, ANAK00412, ANAK00413, ANAK00414, ANAK00415,
Recalling Firm/
Datex - Ohmeda, Inc
Po Box 7550
Madison WI 53707
For Additional Information Contact
Manufacturer Reason
for Recall
Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alrm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected.
FDA Determined
Cause 2
Action Firm mailed recall letters on August 10, 2006, to consignees telling them what to do if a failure occurred during system checkout or during use, as a short term solution. Later, GE representatives will make visits to each site for modification of the interface valve on each device, as the long term solution.
Quantity in Commerce 471
Distribution AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI,
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 = DATEX-OHMEDA, INC.