Events

Recall of Device Recall REMStar Mseries Heated Humidifier System

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

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
    51699
  • Event Risk Class
    Class 2
  • Event Number
    Z-1260-2009
  • Event Initiated Date
    2009-02-05
  • Event Date Posted
    2009-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81028
  • 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
    Ventilator, non-continuous (respirator) - Product Code BZD
  • Reason
    Malfunction of the j3 connection between the heater plate main printed circuit assembly (pca) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier pca.
  • Action
    A Service Communication dated February 5, 2009 was provided to all Respironics customers that are approved to service Respironics devices. The communication described the affected device and actions required. Further questions may be addressed by phone at 1-800-345-6443, and by email at service@respironics.com or clinical@respironics.com.

Device

Device Recall REMStar Mseries Heated Humidifier System
  • Model / Serial
    Catalog Numbers: 1049109, 1049110, 1049111, and AC1049109.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US including states of OR, OH, KY, TX, MO, AZ, IN and NV and countries of United Arab Emirates, Bosnia, Belgium, Bulgaria, Bahrain, Canada, Czech Republic, Denmark, Egypt, Spain, Finland, Greece, Croatia, Hungary, Ireland, Israel, Jordan, Kuwait, Lebanon, Latvia, Macedonia, Netherlands, Norway, Oman, Poland, Portugal, Romania, Qatar, Russia, Slovenia, Turkey, Serbia and South Africa.
  • Product Description
    Remstar Pro M-Series Heated Humidifier System.
  • Manufacturer
    Respironics

Manufacturer

Respironics
  • Manufacturer Address
    Respironics, 1740 Golden Mile Hwy, Monroeville PA 151462012
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA