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U.S. Department of Health and Human Services

Class 3 Device Recall Advisor Vital Signs Monitor

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  Class 3 Device Recall Advisor Vital Signs Monitor see related information
Date Initiated by Firm September 01, 2005
Date Posted November 30, 2005
Recall Status1 Terminated 3 on June 27, 2007
Recall Number Z-0226-06
Recall Event ID 33375
510(K)Number K011177  K982279  K010770  K030407  
Product Classification Electrocardiograph - Product Code DPS
Product Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respiration board (optional circuit board, P/N: 80004B1) installed manufactured with Rev 10 Main boards (P/N: 80002B1) CE/MDD marking, 3-lead 50 Hz ECG and standard SPO2 option.
Code Information serial number: AM05070061
Recalling Firm/
Smiths Medical PM, Inc.
N7w22025 Johnson Dr
Waukesha WI 53186-1856
Manufacturer Reason
for Recall
Potential Safety related problem associated with the pace detect function on some Advisor monitors that have impedance respiration capabilities in that random pace markers may appear when the pace detect function is turned on and the primary lead is set to Lead II, III or any of the augmented leads, AVL, AVR or AVF on the Advisor monitor.
FDA Determined
Cause 2
Action Distirbutors and consignees were notified beginning 09/01/05 via email or phone about Safety Action Bulletin 05-004. Customers were asked to respond to Smiths Medical with a written acknowledgement that they received this Safety Action Bulletin (SAB). The SAB described the issue, actions they should take and instruction on how to have the monitor repaired.
Quantity in Commerce 1
Distribution AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain
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.