Z-0021-2007

GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison...

Name: Z-0021-2007 GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison...
Creator: Datex - Ohmeda, Inc
Published: 2006-08-10
License: https://open.fda.gov/license/

GE Healthcare / initiated 2006-08-10 / Terminated

FDA source

Datex - Ohmeda, Inc began a recall of GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company on 2006-08-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0021-2007
Status: Terminated
Initiated: 2006-08-10
Posted: 2006-11-07
Terminated: 2008-02-24
Recalling firm: GE Healthcare
Product: GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, GE Healthcare, Madison, WI; Datex-Ohmeda, inc., a General Electric company
Product code: BSZ Gas-Machine, Anesthesia
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 root cause: Other
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,
Product codes and lots: 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,

Product code BSZ

K061609Class IIGe Datex-Ohmeda AisysDatex-Ohmeda, Inc. / cleared 2006-06-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)