Events

Recall of Device Recall Advisor Vital Signs Monitor with Capnography

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical PM, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    31505
  • Event Risk Class
    Class 3
  • Event Number
    Z-0826-05
  • Event Initiated Date
    2005-03-16
  • Event Date Posted
    2005-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38858
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrocardiograph - Product Code DPS
  • Reason
    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.
  • 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 (%).

Device

Device Recall Advisor Vital Signs Monitor with Capnography
  • Model / Serial
    serial no. 706573001, 706573002, 706590000 and 706590001
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA and NY within US. Mexico, Argentina, Columbia, Chile, Brazil, Ecuador, Guatemala and Pakistan.
  • Product Description
    Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325.
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • Manufacturer Address
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA