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U.S. Department of Health and Human Services

Class 2 Device Recall Integrated Module Housing

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  Class 2 Device Recall Integrated Module Housing see related information
Date Initiated by Firm August 27, 2012
Date Posted September 14, 2012
Recall Status1 Terminated 3 on April 15, 2013
Recall Number Z-2382-2012
Recall Event ID 63007
510(K)Number K842616  
Product Classification Detector and alarm, arrhythmia - Product Code DSI
Product Ultraview SL 91493 Integrated Module Housing.

PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.
Code Information Domestic - 1493-000275, 1493-000276, 1493-000277, 1493-002469, 1493-002616, 1493-003358, 1493-003359, 1493-003667, 1493-003668, 1493-003669, 1493-003670, 1493-003671, 1493-003672, 1493-003673, 1493-003674, 1493-003675, 1493-003676, 1493-003677, 1493-003678, 1493-003679, 1493-003680, 1493-003681, 1493-003682, 1493-003683, 1493-003684, 1493-003685, 1493-003686, 1493-003687, 1493-003688, 1493-003693, 1493-003694, 1493-003695, 1493-003696, 1493-003697, 1493-003879, 1493-003880, 1493-003881, 1493-003882, 1493-003883, 1493-003884, 1493-003885, 1493-003886, 1493-003887, 1493-003888, 1493-003889, 1493-003890, 1493-003891, 1493-003892, 1493-003893, 1493-003894, 1493-003895, 1493-003896, 1493-003897, 1493-003898, 1493-003899, 1493-003900, 1493-003901, 1493-003902, 1493-003903, 1493-003904, 1493-003905, 1493-003906, 1493-003907, 1493-003908, 1493-003909, 1493-003914, 1493-003915, 1493-003916, 1493-003917, 1493-003918, 1493-003919, 1493-003920, 1493-003921, 1493-003922, 1493-003923, 1493-003924, 1493-003925, 1493-003926, 1493-003927, 1493-003928, 1493-003929, 1493-003930, 1493-003931, 1493-003932, 1493-003933, 1493-003934, 1493-003935, 1493-003936, 1493-003937, 1493-003938, 1493-003939, 1493-003940, 1493-003941, 1493-003942, 1493-003943, 1493-003944, 1493-003945, 1493-003957, 1493-003958, 1493-003959, 1493-003960, 1493-003961, 1493-003962, 1493-003963, 1493-003964, 1493-003965, 1493-003985, 1493-004007, 1493-004011, 1493-004023, 1493-004026, 1493-004027, 1493-004028, 1493-004029, 1493-004030, 1493-004031, 1493-004032, 1493-004033, 1493-004034, 1493-004043, 1493-004044, 1493-004047, 1493-004048, 1493-004050, 1493-004051, 1493-004052, 1493-004053, 1493-004054, 1493-004055, 1493-004056, 1493-004058, 1493-004060, 1493-004064, 1493-004067, 1493-004068, 1493-004069, 1493-004070, 1493-004071, 1493-004075, 1493-004084, 1493-004085, 1493-004086, 1493-004106, 1493-004112, 1493-004113, 1493-004114, 1493-004115, 1493-004116, 1493-004117, 1493-004118, 1493-004119, 1493-004120, 1493-004121, 1493-004122, 1493-004123, 1493-004124, 1493-004125, 1493-004126, 1493-004127, 1493-004128, 1493-004130, 1493-004158, 1493-004159, 1493-004160, 1493-004161, 1493-004162, 1493-004163, 1493-004164, 1493-004172, 1493-004173, 1493-004174, 1493-004175, 1493-004176, 1493-004177, 1493-004178, 1493-004179, 1493-004180, 1493-004181, 1493-004182, 1493-004183, 1493-004184, 1493-004185, 1493-004205, 1493-004206, 1493-004207, 1493-004208, 1493-004209, 1493-004210, 1493-004211, 1493-004212, 1493-004214, 1493-004215, 1493-004216, 1493-004217, 1493-004218, 1493-004219, 1493-004220, 1493-004221, 1493-004222, 1493-004223, 1493-004224, 1493-004225, 1493-004226, 1493-004227, 1493-004228, 1493-004229, 1493-004230, 1493-004231, 1493-004232, 1493-004233, 1493-004234, 1493-004235, 1493-004236, 1493-004237, 1493-004238, 1493-004239, 1493-004240, 1493-004241, 1493-004242, 1493-004243, 1493-004256, 1493-004257, 1493-004258, 1493-004259, 1493-004260, 1493-004261, 1493-004262, 1493-004263, 1493-004264, 1493-004265, 1493-004266, 1493-004267, 1493-004268, 1493-004269, 1493-004270, 1493-004271, 1493-004272, 1493-004273, 1493-004274, 1493-004275, 1493-004276, 1493-004277, 1493-004278, 1493-004279, 1493-004280, 1493-004281, 1493-004282, 1493-004283, 1493-004284, 1493-004285, 1493-004286, 1493-004287, 1493-004288, 1493-004289, 1493-004290, 1493-004291, 1493-004292, 1493-004293, 1493-004294, 1493-004295, 1493-004296, 1493-004297, 1493-004298, 1493-004299, 1493-004301, 1493-004302, 1493-004306, 1493-004307, 1493-004308, 1493-004309, 1493-004310, 1493-004311, 1493-004312, 1493-004313, 1493-004314, 1493-004315, 1493-004316, 1493-004317, 1493-004318, 1493-004319, 1493-004320, 1493-004321, 1493-004322, 1493-004323, 1493-004324, 1493-004325, 1493-004326, 1493-004327, 1493-004328, 1493-004329, 1493-004330, 1493-004331, 1493-004332, 1493-004333, 1493-004334, 1493-004335, 1493-004336, 1493-004337, 1493-004338, 1493-004339, 1493-004340, 1493-004341, 1493-004342, 1493-004343, 1493-004344, 1493-004345, 1493-004346, 1493-004347, 1493-004348, 1493-004349, 1493-004350, 1493-004351, 1493-004352, 1493-004353, 1493-004354, 1493-004355, 1493-004356, 1493-004357, 1493-004358, 1493-004359, 1493-004360, 1493-004361, 1493-004362, 1493-004363, 1493-004364, 1493-004365, 1493-004366, 1493-004367, 1493-004368, 1493-004369, 1493-004370, 1493-004371, 1493-004372, 1493-004373, 1493-004374, 1493-004375, 1493-004376, 1493-004377, 1493-004378, 1493-004379, 1493-004380, 1493-004381, 1493-004382, 1493-004383, 1493-004384, 1493-004385, 1493-004405, 1493-004406, 1493-004407, and 1493-004408.   International - 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Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Llc
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact Spacelabs Healthcare
800-522-7025 Ext. 5970
Manufacturer Reason
for Recall		 There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Spacelabs Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated August 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-522-7025 and select 2 for assistance regarding this recall.
Quantity in Commerce 527 units total; 350 US and 177 International
Distribution Worldwide Distribution.
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 = DSI and Original Applicant = SPACELABS, INC.
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