Spacelabs Healthcare, Llc: 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.

Recall number

Z-2902-2011

Recalling firm

Spacelabs Healthcare, Llc

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.

Status

Terminated

Initiated

2011-06-08

Posted

2011-08-01

Terminated

2011-09-21

Reason

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.

Root cause

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

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.

Lot, serial or model codes

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.

510(k) numbers

["K053599"]

PMA numbers

not on file

Product code

CBR

Firm FEI

3010157426

Firm city

Issaquah

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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