Medical Device Recall: Z-0021-2007

FDA Recalls dataset · Firm: Datex Ohmeda, Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2006-08-10 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0021-2007.

Recall Res Number
Z-0021-2007
Recalling Firm / Manufacturer
FEI Number
2183066
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2006-08-10
Date Posted
2006-11-07
Date Terminated
2008-02-24
Product Code
BSZ
Event Number
36057
Product Quantity
471
Product Description GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company

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.

Action Details 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.

Distribution Pattern AK, AL, CA, FL, KS, KY, MD, MN, MO, NC, NE, SC, SD, TX, VA, WI,

Code Information / Serial Numbers 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, 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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,

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