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Thread: x-laser recall alert

  1. #1
    Join Date
    Apr 2009
    Location
    Seattle, WA
    Posts
    663

    Default x-laser recall alert


  2. #2
    Join Date
    Dec 2009
    Location
    Laurel, MD
    Posts
    368

    Default

    Sorry it's taken me so long to see and reply to this, LDI is nuts.

    So 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.

  3. #3
    Join Date
    Apr 2009
    Location
    Seattle, WA
    Posts
    663

    Default

    Thanks for the reply Adam, really glad to see the way you are handling it vs the way LW did. Sounds like you are making it more than right with your customers and that shows great customer service.

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