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U.S. Department of Health and Human Services

Class 2 Device Recall DeVilbiss Model 515A Oxygen Concentrator

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 Class 2 Recall
DeVilbiss Model 515A Oxygen Concentrator
see related information
Date Posted December 30, 2008
Recall Status1 Open
Recall Number Z-0617-2009
Recall Event ID 50220
Premarket Notification
510(K) Number
K991722 
Product Classification Generator, Oxygen, Portable - Product Code CAW
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
Manufacturer Reason
for Recall
potential for sieve beds to have been incorrectly assembled
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CAW and Original Applicant = SUNRISE MEDICAL HHG, INC.
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