Z-2990-2011

DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea...

Name: Z-2990-2011 DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea...
Creator: Sunrise Medical HHG Inc. dba DeVilbiss Healthcare
Published: 2011-03-11
License: https://open.fda.gov/license/

Sunrise Medical, Inc. / initiated 2011-03-11 / Terminated / root cause: manufacturing process

FDA source

Sunrise Medical HHG Inc. dba DeVilbiss Healthcare began a recall of 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... on 2011-03-11. The reason FDA records is "Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2990-2011
Status: Terminated
Initiated: 2011-03-11
Posted: 2011-08-10
Terminated: 2016-10-24
Recalling firm: Sunrise Medical, Inc.
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.
Product code: BZD Ventilator, Non-Continuous (Respirator)
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: 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.

Product code BZD

K071689Class IIDevilbiss Intellipap Model Dv 5 SeriesSunrise Medical / cleared 2007-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)