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U.S. Department of Health and Human Services

Class 3 Device Recall Ultraview Spacelabs Medical Multigas Analyzer, Model 91518

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  Class 3 Device Recall Ultraview Spacelabs Medical Multigas Analyzer, Model 91518 see related information
Date Initiated by Firm June 08, 2011
Date Posted August 01, 2011
Recall Status1 Terminated 3 on September 21, 2011
Recall Number Z-2902-2011
Recall Event ID 59136
510(K)Number K053599  
Product Classification Nitrous-Oxide Gaseous Phase (anesthetic conc.) Analyzer - Product Code CBR
Product Ultraview Spacelabs Medical Multigas Analyzer, Model 91518, V1.00.14.
Spacelabs Healthcare Llc.

Monitors gas concentrations and alerts clinical personnel when the concentration of anesthetic agents, oxygen, carbon dioxide, or nitrous oxide falls outside of defined limits. The anesthetic agent being administered is automatically identified.
Code Information Model 91518, V1.00.14.  Serial Numbers: 1518-000003, 1518-000008, 1518-000013, 1518-000014, 1518-000016, 1518-000024, 1518-000029, 1518-000036, 1518-000040, 1518-000044, 1518-000226, 1518-000228, 1518-000231, 1518-000233, 1518-000243, 1518-000349, 1518-000354, 1518-000355, 1518-000389, 1518-000399, 1518-000457, 1518-000752, 1518-000819, 1518-000825, 1518-000846, 1518-000948, 1518-000991, 1518-001341, 1518-001393, 1518-001394, 1518-001395, 1518-001522, 1518-001536, 1518-001654, 1518-001655, 1518-001708, 1518-001734, 1518-001736, 1518-001853, 1518-001972, 1518-002065, 1518-002089, 1518-002097, 1518-002114, 1518-002116, 1518-002117, 1518-002118, 1518-002119, 1518-002120, 1518-002121, 1518-002122, 1518-002123, 1518-002124, 1518-002125, 1518-002126, 1518-002127, 1518-002128, 1518-002129, 1518-002130, 1518-002131, 1518-002132, 1518-002133, 1518-002134, 1518-002135, 1518-002136, 1518-002137, 1518-002138, 1518-002139, 1518-002140, 1518-002141, 1518-002142, 1518-002143, 1518-002144, 1518-002145, 1518-002146, 1518-002147, 1518-002148, 1518-002149, 1518-002150, 1518-002151, 1518-002152, 1518-002153, 1518-002154, 1518-002155, 1518-002156, 1518-002157, 1518-002161, 1518-002162, 1518-002163, 1518-002164, 1518-002166, 1518-002167, 1518-002168, 1518-002169, 1518-002170, 1518-002171, 1518-002172, 1518-002173, 1518-002174, 1518-002175, 1518-002176, 1518-002177, 1518-002178, 1518-002179, 1518-002180, 1518-002181, 1518-002182, 1518-002183, 1518-002184, 1518-002185, 1518-002186, 1518-002187, 1518-002188, 1518-002190, 1518-002191, 1518-002192, 1518-002205, 1518-002206, 1518-002207, 1518-002208, 1518-002209, 1518-002210, 1518-002211, 1518-002212, 1518-002213, 1518-002214, 1518-002215, 1518-002216, 1518-002217, 1518-002218, 1518-002219, 1518-002220, 1518-002221, 1518-002222, 1518-002223, 1518-002224, 1518-002225, 1518-002226, 1518-002227, 1518-002228, 1518-002229, 1518-002230, 1518-002231, 1518-002232, 1518-002233, 1518-002234, 1518-002235, 1518-002236, 1518-002237, 1518-002238, 1518-002239, 1518-002240, 1518-002241, 1518-002242, 1518-002243, 1518-002244, 1518-002245, 1518-002246, 1518-002247, 1518-002248, 1518-002249, 1518-002250, 1518-002251, 1518-002252, 1518-002253, 1518-002254, 1518-002255, 1518-002256, 1518-002257, 1518-002258, 1518-002259, 1518-002260, 1518-002261, 1518-002262, 1518-002263, 1518-002264, 1518-002265, 1518-002266, 1518-002267, 1518-002268, 1518-002276, 1518-002277, 1518-002278, 1518-002279, 1518-002280, 1518-002281, 1518-002282, 1518-002283, 1518-002284, 1518-002285, 1518-002286, 1518-002287, 1518-002288, 1518-002289, 1518-002290, 1518-002291, 1518-002292, 1518-002293, 1518-002294, 1518-002295, 1518-002296, 1518-002297, 1518-002298, 1518-002299, 1518-002300, 1518-002301, 1518-002302, 1518-002303, 1518-002304, 1518-002305, 1518-002306, 1518-002307, 1518-002308, 1518-002309, 1518-002310, 1518-002311, 1518-002312, 1518-002313, 1518-002314, 1518-002315, 1518-002316, 1518-002317, 1518-002318, 1518-002319, 1518-002320, 1518-002321, 1518-002322, 1518-002323, 1518-002325, 1518-002326, 1518-002327, 1518-002328, 1518-002329, 1518-002330, 1518-002331, 1518-002332, 1518-002333, 1518-002334, 1518-002335, 1518-002336, 1518-002337, 1518-002338, 1518-002339, 1518-002340, 1518-002341, 1518-002342, 1518-002343, 1518-002344, 1518-002345, 1518-002346, 1518-002347, 1518-002348, 1518-002349, 1518-002350, 1518-002351, 1518-002352, 1518-002353, 1518-002354, 1518-002355, 1518-002356, 1518-002357, 1518-002358, 1518-002359, 1518-002360, 1518-002361, 1518-002362, 1518-002363, 1518-002364, 1518-002365, 1518-002366, 1518-002367, 1518-002368, 1518-002369, 1518-002370, 1518-002371, 1518-002372, 1518-002373, 1518-002374, 1518-002375, 1518-002376, 1518-002377, 1518-002378, 1518-002379, 1518-002380, 1518-002381, 1518-002382, 1518-002383, 1518-002384, 1518-002385, 1518-002386, 1518-002387, 1518-002388, 1518-002389, 1518-002390, 1518-002391, 1518-002392, 1518-002393, 1518-002394, 1518-002395, 1518-002396, 1518-002397, 1518-002398, 1518-002399, 1518-002400, 1518-002401, 1518-002402, 1518-002403, 1518-002404, 1518-002405, 1518-002406, 1518-002407, 1518-002408, 1518-002409, 1518-002410, 1518-002411, 1518-002412, 1518-002413, 1518-002414, 1518-002415, 1518-002416, 1518-002417, 1518-002418, 1518-002419, 1518-002420, 1518-002421, 1518-002422, 1518-002423, 1518-002424, 1518-002425, 1518-002426, 1518-002427, 1518-002428, 1518-002429, 1518-002430, 1518-002431, 1518-002432, 1518-002433, 1518-002434, 1518-002435, 1518-002436, 1518-002437, 1518-002438, 1518-002439, 1518-002440, 1518-002441, 1518-002442, 1518-002443, 1518-002444, 1518-002445, 1518-002446, 1518-002447, 1518-002448, 1518-002451, 1518-002452, 1518-002453, 1518-002454, 1518-002456, 1518-002457, 1518-002458, 1518-002459, 1518-002460, 1518-002461, 1518-002462, 1518-002463, 1518-002464, 1518-002465, 1518-002466, 1518-002467, 1518-002468, 1518-002469, 1518-002470, 1518-002471, 1518-002472, 1518-002476, 1518-002477, 1518-002478, 1518-002479, 1518-002480, 1518-002481, 1518-002482, 1518-002483, 1518-002484, 1518-002485, 1518-002486, 1518-002487, 1518-002488, 1518-002489, 1518-002490, 1518-002491, 1518-002493, 1518-002494, 1518-002495, 1518-002496, 1518-002497, 1518-002498, 1518-002499, 1518-002500, 1518-002501, 1518-002502, 1518-002507, 1518-002508, 1518-002510, 1518-002511, 1518-002513, 1518-002514, 1518-002517, 1518-002518, 1518-002519, 1518-002520, 1518-002521, 1518-002522, 1518-002523, 1518-002524, 1518-002525, 1518-002526, 1518-002527, 1518-002528, 1518-002529, 1518-002530, 1518-002531, 1518-002532, 1518-002533, 1518-002534, 1518-002535, 1518-002536, 1518-002537, 1518-002538, 1518-002539, 1518-002540, 1518-002541, 1518-002542, 1518-002543, 1518-002545, 1518-002549, 1518-002556, 1518-002557, 1518-002558, 1518-002559, 1518-002560, 1518-002561, 1518-002562, 1518-002563, 1518-002564, 1518-002565, 1518-002566, 1518-002567, 1518-002568, 1518-002569, 1518-002570, 1518-002571, 1518-002572, 1518-002573, 1518-002574, 1518-002575, 1518-002576, 1518-002577, 1518-002578, 1518-002579, 1518-002580, 1518-002581, 1518-002582, 1518-002583, 1518-002584, 1518-002585, 1518-002586, 1518-002587, 1518-002588, 1518-002589, 1518-002590, 1518-002591, 1518-002595, 1518-002606, 1518-002607, 1518-002608, 1518-002609, 1518-002610, 1518-002611, 1518-002612, 1518-002613, 1518-002614,  and 1518-005744.
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Llc
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact Technical Support
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall		 Spacelabs received a report of the Model 91518 Multigas Analyzer trending low levels of an anesthetic agent that is not present during a particular case. The error is limited to only the trend table data.
FDA Determined
Cause 2		 Software design
Action Spacelabs Healthcare, Llc. sent a "Customer Bulletin" dated June 20, 2011 to all affected customers. The customers were notified of the trend problem and are advised to follow the instructions in the Perioperative section and the ADMIT/DISCHARGE section of the users manual. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support or 1-425-657-7200 x5089.
Quantity in Commerce 481 units worldwide (333 units internationally and 148 units in the US)
Distribution Worldwide Distribution: (USA) Nationwide distribution, and the countries of ARGENTINA, BAHRAIN, BOLIVIA, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, ECUADOR, EGYPT, FRANCE, INDIA, MEXICO, NICARAGUA, PARAGUAY, PERU, POLAND, Slovakia, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, CHINA, THAILAND, UNITED ARAB EMIRATES, U.K., URUGUAY, VENEZUELA, and VIETNAM.
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 = CBR and Original Applicant = SPACELABS MEDICAL INC.
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