Medical Device Recalls - DeVilbiss Model 515A Oxygen Concentrator
MedSun: Newsletter #33, February 2009

FDA Recall

Date Recall Initiated October 30, 2008

Date Posted December 30, 2008

Recall Number Z-0617-2009

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.

Code Information
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.

Recalling Firm/Manufacturer
Sunrise Medical
100 Devilbiss Dr
Somerset , Pennsylvania 15501-2125

For Additional Information Contact Customer Service 800-338-1988

Reason For Recall 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.

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.

Additional Information:

DeVilbiss Model 515A Oxygen Concentrator Recall. FDA Recall. December 30, 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=74999