Events

Recall of Advisor Vital Signs Monitor

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
    33375
  • Event Risk Class
    Class 3
  • Event Number
    Z-0230-06
  • Event Initiated Date
    2005-09-01
  • Event Date Posted
    2005-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41827
  • 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
    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.
  • 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.

Device

Advisor Vital Signs Monitor
  • Model / Serial
    serial numbers: AM05080008, AM05080009, AM05080010 and AM05080011.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, KS, KY, NY, TN, TX OUS to countries such as: Egypt, France, Iran, Mexico, Peru, Romania, Saudi Arabia and Spain
  • Product Description
    Advisor Vital Signs Monitor (model 9200), catalog number 925474335, 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, standard SPO2 option, Invasive Pressure/Temperature option, printer and battery.
  • 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