DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of pos

FDA device recall Z-1949-2014 · posted 2014-07-01 · Terminated

Recall details

Recalling firm

DeVilbiss Healthcare LLC

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".

Action taken

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 DeVilbiss to be corrected. 3. If you have already distributed any DV5x Series CPAPs included in this serial number list to end users, a patient communication has been included with this notification - a. Insert your contact information at the bottom of the "User Medical Device Correction Letter" included in this notice. b. Forward a copy of the "User Medical Device Correction Letter'' to each user to whom you have provided an affected DV5x Series CPAP unit. If you have one or more of the affected DV5x Series CPAP unit in your possession (as identified in the serial number list) and have any questions regarding the information provided in this communication, please contact DeVilbiss Healthcare Customer Service at 1-800- 338-1988 from 8:00AM-5:00PM EST. [Note: If you have already spoken with a DeVilbiss Healthcare Representative about this issue, there is no need to call unless you have further questions.]

Root cause

Software Manufacturing/Software Deployment

Status

Terminated

Product code

BZD

Quantity affected

1809

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.

Date initiated

2014-05-13

Date posted

2014-07-01

Date terminated

2014-12-02

Location

Somerset, PA

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