Class 2 Device Recall BCI Advisor Vital Signs Monitor, Model 9200

• Date Initiated by Firm: November 29, 2017
• Create Date: July 06, 2018
• Recall Status: Terminated on July 11, 2018
• Recall Number: Z-2379-2018
• Recall Event ID: 80046
• 510(K)Number: K030407
• Product Classification: Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
• Product: BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead/5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
• Code Information: Reorder number 920654235: Serial numbers 4068892, 4068893, 4068894, and 4068895; Reorder number 920654235A: Serial number 4061288; Reorder number 920654335A: Serial numbers 4059004, 4059005, 4068891, and 4069354; Reorder Number 920674235A: 4064435
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• Manufacturer Reason for Recall: Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).
• FDA Determined Cause: Software design
• Action: Smiths Medical sent an Urgent Medical Device Letters dated 11/29/2017 via FedEx tracked mailing. The letter identified the affected product, problem and actions to be taken. For questions call Smith Medical Customer Service at 1-800-258-5361.
• Quantity in Commerce: 10 devices
• Distribution: Worldwide Distribution - US Nationwide in the states of CO and MT. Foreign distribution was to Armenia.
• 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 = CCK