Recall Z-1949-2014 ยท BZD Ventilator, Non-Continuous (Respirator)
DeVilbiss Healthcare LLC
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.
| Date | Jul 1, 2014 (initiated May 13, 2014) |
| Status | Terminated |
| 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". |
| Root cause | Software Manufacturing/Software Deployment |
| Action | DeVilbiss Healthcare sent an Urgent: Medical Device Correction notice dated May 13, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. What to do if you have an affected DV5x Series CPAP unit: 1. Verify your inventory of DV5x Series CPAPs and isolate any units that are on the included serial number list, these units will need to have the serial number corrected. 2. Please contact DeVilbiss Healthcare Customer Service to either request a Sales Representative to correct the issue on site or return the unit back to |
| Quantity | 1809 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay. |
| FDA record | Open on fda.gov |