DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in pat

FDA device recall Z-2990-2011 · posted 2011-08-10 · Terminated

Recall details

Recalling firm

Sunrise Medical HHG Inc. dba DeVilbiss Healthcare

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BZD

Quantity affected

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.

Date initiated

2011-03-11

Date posted

2011-08-10

Date terminated

2016-10-24

Location

Somerset, PA

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