Class 3 Device Recall DeVilbiss

• Date Initiated by Firm: May 13, 2014
• Date Posted: July 01, 2014
• Recall Status: Terminated on December 02, 2014
• Recall Number: Z-1949-2014
• Recall Event ID: 68393
• 510(K)Number: K071689 K091919 K112220
• Product Classification: Ventilator, non-continuous (respirator) - Product Code BZD
• Product: DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
• Code Information: Model # DV51D-HH DV53D-HH DV53D-HH-S DV54D-HH DV54D-HH-S DV55D-HH DV55D-HH-S DV55D-S DV57D-HH serial numbers KD012316 JD034349 JD034384 JD034389 HD070335 HD070339 HD070352 HD070357 HD070377 HD070379 HD070395 HD071128 HD071138 HD071154 HD071278 HD070474 HD070736 JD034560 JD034566 HD070219 HD070162 HD070172 HD070174 HD070178 HD070182 HD070827 HD070961 HD071003 HD071004 HD071007 HD071009 HD071020 HD071021 HD071022 HD071030 HD071032 HD071033 HD071040 HD071043 HD071045 HD071048 HD071057 HD071058 HD071059 HD071062 HD071063 HD071064 HD071065 HD071069 HD071072 JD034492 JD034497 JD034504 JD034506 JD034507 JD034540 JD034543 JD034553 JD034554 JD034555 HD071068 JD034316 JD034317 JD034327 JD034328 JD034329 JD034330 JD034331 JD034332 JD034333 JD034334 HD070167 HD070171 HD070177 HD070190 HD070191 HD070198 HD070206 HD070212 HD070223 HD070225 HD070248 HD070249 HD070279 HD069902 HD069903 HD069906 HD069907 HD070533 HD070534 HD070545 HD070548 HD070563 HD070598 HD070605 JD034598 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• Recalling Firm/ Manufacturer: DeVilbiss Healthcare LLC; 100 Devilbiss Dr; Somerset PA 15501-2125
• For Additional Information Contact: Customer Support; 800-338-1988
• Manufacturer Reason for Recall: A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".
• FDA Determined Cause: Software Manufacturing/Software Deployment
• Action: DeVilbiss Healthcare sent an Urgent: Medical Device Correction notice dated May 13, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. What to do if you have an affected DV5x Series CPAP unit: 1. Verify your inventory of DV5x Series CPAPs and isolate any units that are on the included serial number list, these units will need to have the serial number corrected. 2. Please contact DeVilbiss Healthcare Customer Service to either request a Sales Representative to correct the issue on site or return the unit back to DeVilbiss to be corrected. 3. If you have already distributed any DV5x Series CPAPs included in this serial number list to end users, a patient communication has been included with this notification - a. Insert your contact information at the bottom of the "User Medical Device Correction Letter" included in this notice. b. Forward a copy of the "User Medical Device Correction Letter'' to each user to whom you have provided an affected DV5x Series CPAP unit. If you have one or more of the affected DV5x Series CPAP unit in your possession (as identified in the serial number list) and have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800- 338-1988 from 8:00AM-5:00PM EST. [Note: If you have already spoken with a DeVilbiss Healthcare Representative about this issue, there is no need to call unless you have further questions.]
• Quantity in Commerce: 1809
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BZD and Original Applicant = DEVILBISS HEALTHCARE LLC; 510(K)s with Product Code = BZD and Original Applicant = SUNRISE MEDICAL