Events

Recall of NeoPAP

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
    35608
  • Event Risk Class
    Class 2
  • Event Number
    Z-1191-06
  • Event Initiated Date
    2005-09-19
  • Event Date Posted
    2006-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46463
  • 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, Continuous - Product Code CBK
  • Reason
    Gas input pressures over 62 psi may cause cpap pressure oscillation.
  • Action
    The recalling firm issued a recall letter to their customers dated 9/19/05 informing them of the problem and the corrective action. (fitting unit with external 50 psi pressure regulator for both air and oxygen)

Device

NeoPAP
  • Model / Serial
    Serial numbers 5310050616-01, 5310050616-02, 5310050621-01
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    World wide (including medical facilities in AZ, CA, CO, GA, IA, IL, MA, MD, MN, MO, NC, NE, NH, NJ, OH, OK, OR, PA, PR, TN, TX, VA, WI, and WV. Japan, Ireland, Great Britain, Sweden, Portugal, France, Chile, Argentina, Hong Kong, South Africa, Greece, Egypt, Saudia Arabia, Norway, Spain, Belgium and Canada
  • Product Description
    NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
  • 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