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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraview SL Command Module/Multiparameter input module

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  Class 2 Device Recall Ultraview SL Command Module/Multiparameter input module see related information
Date Initiated by Firm January 03, 2007
Date Posted February 27, 2007
Recall Status1 Terminated 3 on February 15, 2011
Recall Number Z-0523-2007
Recall Event ID 37077
510(K)Number K050605  
Product Classification multiparameter patient monitor - Product Code DSI
Product Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.
Code Information Serial numbers 1496-004112, 1496-005720, 1496-004094, 1496-004088, 1496-004089, 1496-004090, 1496-004091, 1496-004092, 1496-004093, 1496-004110, 1496-011601, 1496-004111, 1496-010974, 1496-010975, 1496-010977, 1496-011021, 1496-004174, 1496-004175, 1496-004177, 1496-004178, 1496-004179, 1496-004180, 1496-004165, 1496-004166, 1496-009201, 1496-006236, 1496-006432, 1496-006434, 1496-008163, 1496-008164, 1496-005413, 1496-011026, 1496-006435, 1496-006436, 1496-006829, 1496-006830, 1496-006831, 1496-006832, 1496-006895, 1496-006912, 1496-006913, 1496-006914, 1496-009137, 1496-009138, 1496-004108, 1496-004109, 1496-005761, 1496-008497, 1496-008498, 1496-008499, 1496-008500, 1496-008501, 1496-010056, 1496-010057, 1496-005369, 1496-005388, 1496-005412, 1496-010607, 1496-010053, 1496-005254, 1496-005255, 1496-005256, 1496-005257, 1496-005258, 1496-005326, 1496-005327, 1496-005328, 1496-005329, 1496-004075, 1496-004076, 1496-004077, 1496-004078, 1496-004079, 1496-004080, 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Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Incorporated
5150 220th Ave Se
Issaquah WA 98029-6834
Manufacturer Reason
for Recall		 Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment.
FDA Determined
Cause 2		 Other
Action On 1/3/07 the firm issued a letter to their customers advising of the issues and provided guidance to the consignee to enable the Check Setup feature that will provide an audible prompt whenever the monitor resets. The letter advises that consignees will be contacted to schedule an update, once new software has been validated.
Quantity in Commerce 1347 devices; 1067 domestic and 280 international
Distribution Nationwide and worldwide.
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 MEDICAL INC.
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