Class 3 Device Recall Advisor Vital Signs Monitor

• Date Initiated by Firm: September 01, 2005
• Date Posted: November 30, 2005
• Recall Status: Terminated on June 27, 2007
• Recall Number: Z-0234-06
• Recall Event ID: 33375
• 510(K)Number: K010770 K011177 K030407 K982279
• Product Classification: Electrocardiograph - Product Code DPS
• Product: Advisor Vital Signs Monitor (model 9200), catalog number 925674325, 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 60 Hz ECG, standard SPO3 option, Invasive Pressure/Temperature and battery.
• Code Information: serial numbers: AM05070113, AM05070114, AM05070115, AM05070116, AM05070117, AM05070118, AM05070119, AM05070120, AM05070121 and AM05070122
• Recalling Firm/ Manufacturer: 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: Other
• 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: 10
• 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; 510(K)s with Product Code = DPS