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US: FDA recalls certain X-Laser light show projectors

On November 18 2017, the U.S. Food and Drug Administration announced recall Z-2870-2017 of X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, and Hawk 500, for failure to comply with performance standard requirements (21 CFR 1040.10(f)) when operated in the user accessible auto and music modes of operation.

FDA listed the following actions:

X-Laser LLC will bring into compliance:
     1. All purchasers and associated dealers of affected LLS projector models will be notified by mail and email of their failure to comply with the performance standard. The notification will follow the format and include the information required by 21 CFR 1003.21. Those that do not respond within 14 days will be notified a second time. Those not responding to the second attempt will be notified again every 6 months for the next 2 years. Non-responsive dealers will be ineligible for future orders.
     2. All affected LLS projectors will be repaired by removing the auto and music modes from the dipswitch accessible settings, after which, these modes will only be accessible through the DMX connection. These actions, including transportation of the LLS projector, will be made free of charge.
     3. All LLS projector models that X-Laser receives, regardless of purpose, will be checked for dipswitch accessible auto or music modes and repaired if needed.
     4.Corrective actions will be completed within 120 days of receipt of this letter.
For further questions please call (866) 702-7768.

For additional details from X-Laser, click the “read more” link.
On November 19 2017, X-Laser’s Adam Raugh posted information to Facebook:

In May of this year I was contacted by CDRH about the presence of auto testing modes on some of our DJ level products. When we filed the product report on these laser projectors CDRH approved it with these modes as being marked in the documentation for bench testing only.

With some of the staffing changes at CDRH, this was reevaluated and determined to no longer be acceptable in conjunction with how we satisfied the remote interlock requirement. To satisfy CDRH we had to make the choice of either removing this testing mode or changing how the remote interlock is handled. We chose to remove this mode as that would have no effect on anyone using the projector in a compliant fashion.

This corrective action affects a fairly small number of the projectors we have out in the field and we've been sending notifications to those affected. Here's some of the text of our notification:

     "So what is X-Laser going to do about it? We have had some back and forth with FDA and CDRH and we have a solution that will allow us to bring the laser back into compliance with minimal modifications. This means the laser will need to come back to our facility for a small internal modification. This modification WILL NOT affect how you use the laser in the field, it just changes now you access the auto and sound active testing modes. After this modification is made we will notify FDA that your projector is in compliance and they will process your variance as approved.

     X-Laser will cover all shipping costs and to thank you for your patience we will give the projector a free cleaning, a 2 YEAR FULL WARRANTY on the projector from the date of recertification, a free X-Laser t-shirt and sticker pack and a package of free laser shows for any ILDA compatible laser. The value of this package is between $250 and $800 depending on the projector The modification process requires very little time and we'll get the laser right back out to you.

     What do we need from you? Please just reply to this email with a list of your lasers with serial numbers and your shipping address, we'll send you an email with a shipping label and further instructions.

     We are sorry for the inconvenience but this is something we must do due to the changes at FDA. Thank you for giving us the opportunity to prove to you that we stand behind our products.

     If you have any questions or comments about this, please contact me directly at adam@x-laser.com"

We've been completing these retrofits as directed and all is well between CDRH and X-Laser.

TL,DR: CDRH changed how we were allowed to do something minor, so we're fixing it without putting up a fight about it. Sorry it's not more dramatic or exciting folks but it's not a particular big deal.

Thank you for giving me the opportunity to respond and be a part of this community.