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U.S. Department of Health and Human Services

Class 3 Device Recall Advisor Vital Signs Monitor with Capnography

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  Class 3 Device Recall Advisor Vital Signs Monitor with Capnography see related information
Date Initiated by Firm March 16, 2005
Date Posted May 12, 2005
Recall Status1 Terminated 3 on December 31, 2006
Recall Number Z-0825-05
Recall Event ID 31505
510(K)Number K011177  K982279  K010770  K030407  
Product Classification Electrocardiograph - Product Code DPS
Product Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335.
Code Information serial no. 706741003
Recalling Firm/
Smiths Medical PM, Inc.
N7w22025 Johnson Dr
Waukesha WI 53186-1856
Manufacturer Reason
for Recall
Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.
FDA Determined
Cause 2
Action On March 16, 2005, customers were emailed Safety Action Bulletin 05-003 informing them of the low CO2 (End Tidal and Inspired) measurements in percent (%) and urging them to use mmHg or kPa as the unit of measurement . In addition, a Technical Worksheet will be distributed to customers who request a software upgrade. The Technical Worksheet will instruct them how to perform the software upgrade which corrects the CO2 measurements (End Tidal and Inspired) in percent (%).
Quantity in Commerce 1
Distribution CA and NY within US. Mexico, Argentina, Columbia, Chile, Brazil, Ecuador, Guatemala and Pakistan.
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 = DPS and Original Applicant = BCI INTL., INC.
510(K)s with Product Code = DPS and Original Applicant = BCI, INC.