Budapest Announcement About An INDIGO Software "Recall"

There was an announcement that was released to the Practitioners from the Budapest Home Office (BHO) regarding an INDIGO Software “recall”   This message was sent by way of their QxSubspace Newsletter (Click to read) on December 14, 2012.

Prof Nelson/Desire’ Dubounet in previous dialogue with TQA stated that this was a mandatory Class I FDA recall.  This recent announcement also implied that failure to do this software update would render the INDIGO as FDA noncompliant and further stated that “failure to update will result in confiscation, civil and/or criminal charges”. This language has caused much undue stress to the Indigo Practitioners.  An FDA recall and any subsequent action on this level would only occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
Quantum World Vision (QWV) is the manufacturer of the INDIGO device https://www.quantumworldvision.com/  In the event of a device investigation or recall (at the level described in the newsletter released by QxSubspace; from whom we license the Indigo software) would have involved the Regulatory/Compliance Quality Control manager.  This department of QWV has not been notified, nor have they been presented with any data to review by the FDA or any other source..

The other comment in this announcement was that the Software update release date would be on Monday, the 17th of December 2012, and it would have an activation fee of 200 EUR  The announcement was encouraging practitioners to do this update before the 25th to get a discount.

The software was not ready but the announcement was sent out by them anyway which caused confusion.  Instead it was released at the start of the holidays and the discount to update was extended to Jan 1st. The 12 12 12 software update files were not provided to us before the release so that the proper regulatory process of Beta Testing could ensue.  All practitioners doing this update will be beta testers.  Currently there is no guarantee how well this version of the software will perform.

You can find the INDIGO device on the FDA website by going to this link http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm 

On this page you can type ‘Quantum World Vision’ to find the Indigo device listing.  When the page loads you can click on the ‘Product’

You can also open the regulation number 882.5050  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=882.5050     

Here you will see that it is classified as a Class II Biofeedback device under the medical Specialty Neurology.

This is the link to the FDA Medical Device Recall page http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm