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U.S. Department of Health and Human Services

Class 2 Device Recall DeVilbiss Model DV5x Series CPAP with Heated Humidifier

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  Class 2 Device Recall DeVilbiss Model DV5x Series CPAP with Heated Humidifier see related information
Date Initiated by Firm March 11, 2011
Date Posted August 10, 2011
Recall Status1 Terminated 3 on October 24, 2016
Recall Number Z-2990-2011
Recall Event ID 59042
510(K)Number K071689  
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
Product DeVilbiss Model DV5x Series CPAP with Heated Humidifier

Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.
Code Information Model number DV5HH, serial number range from HH073341 to HH077139.  Model number DV51D-HH, serial number range from ID022837 to ID023117.  Model number DV53-HH, serial number range from JD004065 to JD004224.  Model number DV54D-HH, serial number range from HD023473 to HD024014.  Model number DV55D-HH, serial number range from KD005598 to KD005695.  
Recalling Firm/
Manufacturer		 Sunrise Medical HHG Inc. dba DeVilbiss Healthcare
100 DeVilbiss Drive
Somerset PA 15501-2125
For Additional Information Contact James P. Froehlich
814-443-7692
Manufacturer Reason
for Recall		 Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, DeVilbiss Healthcare, issued a "URGENT: MEDICAL DEVICE CORRECTION" letter dated March 11, 2011 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to verify their inventory of CPAPs with Heated Humidifiers and isolate any units that are included in the list; replace the humidifier chamber o-rings with the new ones provided; discard the original o-ring removed from the humidifier chamber; complete and return the URGENT: MEDICAL DEVICE CORRECTION Confirmation letter via mail to Quality Manager, DeVilbiss Healthcare LLC, 100 DeVilbiss Drive, Somerset, PA, 15501; affirm that all units have been corrected and that all end users have been sent replacement parts, when all of the CPAPs on the serial number list have been corrected, and return a copy of the sign serial number sheet as confirmation. If you have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800-388-1988 from 8:00AM-5:00PM EST.
Quantity in Commerce 210
Distribution Worldwide distribution; USA (nationwide) including states of AL, AR, CA, FL, IL, IN, IA, KS, KY, MD, MA, MI, MS, NE, NJ, NY, OH, PA, WA, WV, and WI; and countries of Europe.
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 = SUNRISE MEDICAL
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