Class 2 Device Recall GE Healthcare DatexOhmeda Aisys

• Date Initiated by Firm: August 10, 2006
• Date Posted: November 07, 2006
• Recall Status: Terminated 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, 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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/ Manufacturer: Datex - Ohmeda, Inc; Po Box 7550; Madison WI 53707
• For Additional Information Contact: 608-221-1551
• 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: 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,
• 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.