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U.S. Department of Health and Human Services

Class 2 Device Recall BCI Advisor

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 Class 2 Recall
BCI Advisor
see related information
Date Posted July 23, 2007
Recall Status1 Terminated on October 29, 2008
Recall Number Z-1089-2007
Recall Event ID 38128
Premarket Notification
510(K) Numbers
K010770  K030407  K982279 
Product Classification Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) - Product Code MWI
Product BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
Code Information Serial Number AM07030098 AM07030097 AM07030100 AM07030099 AM07030018 AM07020155 AM07020154 AM07020152 AM07020153 AM07030010 AM07030005 AM07030013 AM07030014 AM07030015 AM07030012 AM07030006 AM07030008 AM07030011 AM07030016 AM07030017 AM07030004 AM07030009 AM07030007 AM07030000 AM07030001 AM07030101 AM07030103 AM07030019 AM07020159 AM07020164 AM07020163 AM07020161 AM07020165 AM07020166 AM07020157 AM07020162 AM07020158 AM07020160 AM07020049 AM07020047 AM07020039 AM07020048 AM07020050 AM07020064 AM07030002 AM07030003 AM07030148 AM07030114 AM07020179 AM07020168 AM07020167 AM07030112 AM07020173 AM07020172 AM07020126 AM07030109 AM07020169
Recalling Firm/
Manufacturer
Smiths Medical PM, Inc.
N7w22025 Johnson Dr
Waukesha, Wisconsin 53186-1856
Manufacturer Reason
for Recall
Turn off unexpectedly/ Not turn on : monitors turned off unexpectedly sounding the critical failure alarm. Advisor Vital Signs monitors that were off, would not turn back on.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Consignees will be contacted via a Safety Action Bulletin 07-SAB02 dated June 5, 2007. Technical Worksheet, 07-TW01 including a kit will be sent to the International consignees whom Technical Service has deemed qualified to perform the repair. The repair will be performed at the consignee site. International consignees who require or request the repair be done at the Smiths Medical PM, Inc. Technical Service department will return their monitors for repair.
Quantity in Commerce 57
Distribution International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = BCI INTL., INC.
510(K)s with Product Code = MWI and Original Applicant = BCI, INC.
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