Events

Recall of Device Recall DeVilbiss iFill Personal Oxygen Station model number 535D

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

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
    36174
  • Event Risk Class
    Class 3
  • Event Number
    Z-0038-2007
  • Event Initiated Date
    2006-08-24
  • Event Date Posted
    2006-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48128
  • 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
    Generator, Oxygen, Portable - Product Code CAW
  • Reason
    Potential for oxygen cylinders to not fill completely.
  • Action
    The recalling firm began to notify customers via telephone beginning on 8/24/06. An 'Urgent Medical Device Recall' letter was sent on 8/28/06. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. A customer service help line has been established (1-800-333-4000) to provide additional information for returning units.

Device

Device Recall DeVilbiss iFill Personal Oxygen Station model number 535D
  • Model / Serial
    serial numbers AD01145 through AD01462
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distriubted to 252 end users nationwide through 36 dealers.
  • Product Description
    DeVilbiss iFill Personal Oxygen Station model number 535D.
  • Manufacturer
    Sunrise Medical

Manufacturer

Sunrise Medical
  • Manufacturer Address
    Sunrise Medical, 100 Devilbiss Dr, Somerset PA 15501-2125
  • Source
    USFDA