||July 23, 2007
||Terminated on October 29, 2008
|Recall Event ID
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) - Product Code MWI
||BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
|Smiths Medical PM, Inc.
N7w22025 Johnson Dr
Waukesha, Wisconsin 53186-1856
|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.
|COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
||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
||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)s with Product Code = MWI and Original Applicant = BCI INTL., INC.
510(K)s with Product Code = MWI and Original Applicant = BCI, INC.