Events

Recall of DeVilbiss Model 515A Oxygen Concentrator

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
    50220
  • Event Risk Class
    Class 2
  • Event Number
    Z-0617-2009
  • Event Initiated Date
    2008-10-30
  • Event Date Posted
    2008-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74999
  • 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
    Portable Oxygen Generator - Product Code CAW
  • Reason
    Potential for sieve beds to have been incorrectly assembled.
  • Action
    On 10/30/08, the recalling firm began to telephone customers of the problem. The recalling firm followed up with Urgent: Medical Device Recall letters, dated 11/7/2008. The letters requested that users cease the use of the affected device and immediately contact their provider to make arrangements to have the Concentrator replaced. The firm has set up a toll free line to assist customers with identification of affected units and the return process.

Device

DeVilbiss Model 515A Oxygen Concentrator
  • Model / Serial
    Model 515ADS - serial number range A561137DS - A562049DS; Model 515ADZ - serial number range A538908DZ - A538924DZ; Model 515AKS - serial number range A542879KS - A543722KS; and Model 515AKZ - serial number A501627KZ.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, CA, FL ,GA, IN, IL, MA, MD, MI, MS, NC, NE, NH, NM, NY, PA, SD, TN, TX, VA, and WI, and countries of Canada, Columbia, Germany, Mexico, Netherlands, Singapore, and United Kingdom.
  • Product Description
    DeVilbiss Model 515A Oxygen Concentrator || Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities.
  • Manufacturer
    Sunrise Medical

Manufacturer

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