Z-0617-2009

DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These...

Name: Z-0617-2009 DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These...
Creator: Sunrise Medical
Published: 2008-10-30
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2008-10-30 / Terminated / root cause: design

FDA source

Sunrise Medical began a recall of DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and... on 2008-10-30. The reason FDA records is "potential for sieve beds to have been incorrectly assembled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0617-2009
Status: Terminated
Initiated: 2008-10-30
Posted: 2008-12-30
Terminated: 2012-10-27
Recalling firm: Sunrise Medical, Inc.
Product: 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.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: potential for sieve beds to have been incorrectly assembled
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 428 units
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 codes and lots: 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 code CAW

K991722Class IIDevilbiss 5 Liter Oxygen ConcentratorSunrise Medical Hhg, Inc. / cleared 1999-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)