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.
This recall has been terminated (originally issued December 30, 2008).
- Company
- Sunrise Medical
- Recall Initiated
- October 30, 2008
- Posted
- December 30, 2008
- Terminated
- October 27, 2012
- Recall Number
- Z-0617-2009
- Quantity
- 428 units
- Firm Location
- Somerset, PA
- Official Source
- View on FDA website ↗
Reason for Recall
potential for sieve beds to have been incorrectly assembled
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.
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
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.