Events

Recall of Device Recall MODEL 520A NOVAMETRIX PULSE OXIMETER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dixtal Medical, 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
    52041
  • Event Risk Class
    Class 2
  • Event Number
    Z-1559-2009
  • Event Initiated Date
    2009-05-13
  • Event Date Posted
    2009-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81973
  • 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
    Oximeter - Product Code DQA
  • Reason
    Neonatal/pediatric spu sensors may be incorrectly packaged in pouches labeled for adult/pediatric spu sensors.
  • Action
    Urgent Product Recall Notification was issued to affected accounts by email/facsmile on May 8, 2009 requesting to cease distribution, quarantine and return recalled product. Contact Dixtal Medical with questions; to inquire about your on-hand inventory; or to arrange to receive replacement product at Customer Service: sales@dixtal.com, Phone Number 1-203-269-1112, Fax Number 1-203-269-1760.

Device

Device Recall MODEL 520A NOVAMETRIX PULSE OXIMETER
  • Model / Serial
    Lot Number: 26020906, 27020906, 17040906, 21040906 and 22040906.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (TX and CT) and countries of Italy, Japan, France and Turkey.
  • Product Description
    Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style || Catalog #: 6480-25. || The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters.
  • Manufacturer
    Dixtal Medical, Inc.

Manufacturer

Dixtal Medical, Inc.
  • Manufacturer Address
    Dixtal Medical, Inc., 101 N Plains Industrial Rd Bldg 2, Wallingford CT 06492-2360
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA