Events

Recall of SmartMonitor 2 Infant Apnea Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics, 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
    51886
  • Event Risk Class
    Class 1
  • Event Number
    Z-1411-2009
  • Event Initiated Date
    2009-04-23
  • Event Date Posted
    2009-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81546
  • 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
    Monitor, apnea, facility use - Product Code FLS
  • Reason
    Audible alarm failure.
  • Action
    A notification letter dated April 23, 2009 was issued to consignees informing them of the issue. Consignees were instructed to locate the affected units in their inventory and return them to Philips Children's Medical Ventures-Youngwood Service. Any units that were shipped by consignees to their customers are to be retrieved and returned to Respironics. Consignees were also instructed to complete the enclosed Business Reply Form and Serial Number Reconciliation List and fax to Stericycle at 888-345-5369 or email to respironics1985@stericycle.com. For questions and additional information about the recall, contact Stericycle Customer Service by calling at 888-345-4630.

Device

SmartMonitor 2 Infant Apnea Monitor
  • Model / Serial
    Model Number 4002; Serial Numbers 3000033364 through 3000038740 and Model Number 4003; Serial Numbers 3000033364 through 3000038740.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    SmartMonitor 2 Infant Apnea Monitor. || The monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Manufacturer Address
    Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668-8517
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA