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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. Click to read more...
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. Click to read more...