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U.S. Department of Health and Human Services

Class 2 Device Recall Aisys

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  Class 2 Device Recall Aisys see related information
Date Initiated by Firm February 05, 2009
Date Posting Updated June 23, 2009
Recall Status1 Terminated 3 on December 10, 2011
Recall Number Z-1425-2009
Recall Event ID 51202
510(K)Number K073707  
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.
Code Information AL01197, ANAL01198, ANAL01199, ANAL01200, ANAL01201, ANAL01202, ANAL01203, ANAL01205, ANAL01206, ANAL01214, ANAL01215, ANAL01216, ANAL01217, ANAL01218, ANAL01219, ANAL01220, ANAL01221, ANAL01222, ANAL01223, ANAL01224, ANAL01225, ANAL01226, ANAL01227, ANAL01228, ANAL01229, ANAL01230, ANAL01231, ANAL01232, ANAL01233, ANAL01234, ANAL01235, ANAL01236, ANAL01237, ANAL01238, ANAL01239, ANAL01240, ANAL01241, ANAL01242, ANAL01243, ANAL01244, ANAL01245, ANAL01246, ANAL01254, ANAL01255, ANAL01258, ANAL01279, ANAL01287, ANAL01300, ANAL01302, ANAL01303, ANAL01304, ANAL01305, ANAL01306, ANAL01308, ANAL01325, ANAL01326, ANAL01327, ANAL01328, ANAL01329, ANAL01336, ANAL01337, ANAL01338, ANAL01339, ANAL01340, ANAL01341, ANAL01345, ANAL01346, ANAL01347, ANAL01348, ANAL01349, ANAL01350, ANAL01383, ANAL01384, ANAL01385, ANAL01386, ANAL01387, ANAL01388, ANAL01389, ANAL01394, ANAL01395, ANAL01397, ANAL01398, ANAL01399, ANAL01400, ANAL01401, ANAL01402, ANAL01403, ANAL01404, ANAL01405, ANAL01406, ANAL01407, ANAL01408, ANAL01409, ANAL01410, ANAL01415, ANAL01416, ANAL01418, ANAL01427, ANAL01428, ANAL01429, ANAL01430, ANAL01431, ANAL01432, ANAL01433, ANAL01434, ANAL01435, ANAL01436, ANAL01437, ANAL01438, ANAL01439, ANAL01440, ANAL01441, ANAL01442, ANAL01443, ANAL01444, ANAL01445, ANAL01446, ANAL01447, ANAL01448, ANAL01449, ANAL01450, ANAL01451, ANAL01452, ANAL01453, ANAL01454, ANAL01455, ANAL01456, ANAL01457, ANAL01458, ANAL01461, ANAL01462, ANAL01463, ANAL01464, ANAL01465, ANAL01467, ANAL01468, ANAL01469, ANAL01470, ANAL01471, ANAL01472, ANAL01473, ANAL01474, ANAL01475, ANAL01476, ANAL01477, ANAL01478, ANAL01479, ANAL01480, ANAL01481, ANAL01482, ANAL01483, ANAL01486, ANAL01487, ANAL01488, ANAL01489, ANAL01490, ANAL01491, ANAL01492, ANAL01493, ANAL01494, ANAL01495, ANAL01496, ANAL01497, ANAL01498, ANAL01499, ANAL01500, ANAL01501, ANAL01502, ANAL01506, ANAL01507, ANAL01508, ANAL01509, ANAL01510, ANAL01511, ANAL01512, ANAL01513, ANAL01514, ANAL01515, ANAL01516, ANAL01517, ANAL01518, ANAL01519, ANAL01520, ANAL01521, ANAL01522, ANAL01523, ANAL01524, ANAL01525, ANAL01526, ANAL01527, ANAL01528, ANAL01529, ANAL01530, ANAL01531, ANAL01532, ANAL01533, ANAL01534, ANAL01535, ANAL01536, ANAL01537, ANAL01538, ANAL01551, ANAM00109, ANAM00110, ANAM00111, ANAM00112, ANAM00113, ANAM00114, ANAM00115, ANAM00116, ANAM00117, ANAM00118, ANAM00119, ANAM00120, ANAM00121, ANAM00122, ANAM00123, ANAM00126, ANAM00158, ANAM00159, ANAM00160, ANAM00161, ANAM00162, ANAM00163, ANAM00164, ANAM00165, ANAM00166, ANAM00167, ANAM00168, ANAM00169, ANAM00170, ANAM00171, ANAM00172, ANAM00173, ANAM00174, ANAM00175, ANAM00176, ANAM00177, ANAM00187, ANAM00188, ANAM00189, ANAM00190, ANAM00191, ANAM00192, ANAM00193, ANAM00194, ANAM00195, ANAM00196, ANAM00197, ANAM00198, ANAM00199, ANAM00200, ANAM00201, ANAM00206, ANAM00207, ANAM00208, ANAM00227, ANAM00228, ANAM00229, ANAM00230, ANAM00231, ANAM00232, ANAM00233, ANAM00234, ANAM00235, ANAM00236, ANAM00237, ANAM00238, ANAM00239, ANAM00240, ANAM00241, ANAM00242, ANAM00243, ANAM00244, ANAM00245, ANAM00246, ANAM00247, ANAM00248, ANAM00249, ANAM00250, ANAM00251, ANAM00252, ANAM00253, ANAM00263, ANAM00264, ANAM00272, ANAM00273, ANAM00274, ANAM00276, ANAM00277, ANAM00278, ANAM00292, ANAM00293, ANAM00294, ANAM00295, ANAM00296, ANAM00297, ANAM00298, ANAM00299, ANAM00300, ANAM00301, ANAM00302, ANAM00303, ANAM00304, ANAM00305, ANAM00306, ANAM00307, ANAM00308, ANAM00309, ANAM00310, ANAM00311, ANAM00312, ANAM00313, ANAM00314, ANAM00367, ANAM00368, ANAM00369, ANAM00370, ANAM00371, ANAM00372, ANAM00373, ANAM00374, ANAM00377, ANAM00378, ANAM00379, ANAM00380, ANAM00381, ANAM00382, ANAM00383, ANAM00384, ANAM00385, ANAM00386, ANAM00387, ANAM00388, ANAM00389, ANAM00390, ANAM00391, ANAM00392, ANAM00393, ANAM00394, ANAM00395, ANAM00396, ANAM00397, ANAM00398, ANAM00399, ANAM00400, ANAM00401, ANAM00402, ANAM00403, ANAM00404, ANAM00405, ANAM00406, ANAM00407, ANAM00408, ANAM00409, ANAM00410, ANAM00421, ANAM00423, ANAM00424, ANAM00425, ANAM00426, ANAM00427, ANAM00439, ANAM00440
Recalling Firm/
Manufacturer
GE Healthcare
9900 Innovation Drive
Mail Stop: RP2138
Wauwatosa WI 53226
Manufacturer Reason
for Recall
Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch. If the clinician does not intervene, the patient could experience hypoventilation leading to h
FDA Determined
Cause 2
Component design/selection
Action GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.
Quantity in Commerce 3082
Distribution Worldwide distribution: USA, Canada, Mexico, YEMEN, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TUrKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, PERU, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LITHUANIA, LIBYA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLoMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA.
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.
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