Events

Recall of Dixtal Handheld Pulse Oximetry

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
    57045
  • Event Risk Class
    Class 2
  • Event Number
    Z-0550-2011
  • Event Date Posted
    2010-12-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95236
  • 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
    Unit may overestimate sp02 levels in a high humidity environment.
  • Action
    Dixtal Medical notified accounts by email on 9/27/10 and followed by hard copy Urgent Product Recall letter, dated September 27, 2010. The letter identified the affected product and stated the reason for the recall. The letter also requested that customers to cease distribution and/or use of the suspect product and to return product for replacement. The attached Confirmation Notification should be completed and returned. Customers are to contact Customer Service: sales@dixtal.com, Phone 1-203-269-1112, Fax 1-203-269-1760, with questions or to arrange to have a replacement product provided.

Device

Dixtal Handheld Pulse Oximetry
  • Model / Serial
    Serial Numbers: 139-31479, 139-31485, 139-31465 TO 139-31478,  139-31483 AND 139-31489, 139-31490, 139-31493,  139-31494, 139-31499, 139-31511, 139-31514, 139-31515, 139-31522, 139-31526 & 139-31529, 139-31487, 139-31512 139-31480, 139-31463, 139-31486, 139-31491, 139-31462
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of AK, KY, NJ, and NY and countries of Australia, Austria, Bolivia, Canada, Finland, Indonesia, Italy, Poland, Sweden, and Switzerland.
  • Product Description
    Dixtal Handheld Pulse Oximetry Model 513 || Catalog Number: 9300-00
  • 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