Recall Z-2990-2011 ยท BZD Ventilator, Non-Continuous (Respirator)
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 remo
| Date | Aug 10, 2011 (initiated Mar 11, 2011) |
| Status | Terminated |
| 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, 1 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071689 | DEVILBISS INTELLIPAP MODEL DV 5 SERIES Sunrise Medical, Sep 7, 2007 |