FDA Medical Device Recalls (openFDA)
Sunrise Medical HHG Inc. dba DeVilbiss Healthcare: 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.
- Recall number
- Z-2990-2011
- Recalling firm
- Sunrise Medical HHG Inc. dba DeVilbiss Healthcare
- 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.
- Status
- Terminated
- Initiated
- 2011-03-11
- Posted
- 2011-08-10
- Terminated
- 2016-10-24
- Reason
- Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K071689"]
- PMA numbers
- not on file
- Product code
- BZD
- Firm FEI
- 2515872
- Firm city
- Somerset
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28