Recall Z-1949-2014— DeVilbiss Healthcare LLC
Class III · Terminated
Class III FDA medical device recall by DeVilbiss Healthcare LLC, initiated 2014-05-13, terminated 2014-12-02. It names 3 FDA 510(k) clearances: K112220, K091919, K071689. Product: DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.. Reason: A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST"..
- Recalling firm
- DeVilbiss Healthcare LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-05-13
- Terminated
- 2014-12-02
- Firm location
- Somerset, PA, United States
510(k) clearances named in this recall
3 on FDA's record- K112220 — DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
- K091919 — DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST
- K071689 — DEVILBISS INTELLIPAP MODEL DV 5 SERIES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
Reason for recall
A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".
Data sourced from openFDA. This site is unofficial and independent of the FDA.