A comprehensive resource for safe and responsible laser use
On Dec. 22, 2017, Santajoy initiated a nationwide recall of Galaxy Holiday Laser Lights and Northern Lights Holiday Laser Lights. These laser projection products may incorporate a laser having a higher output than intended and fail to comply with FDA performance standard requirements (21 CFR 1040.10 and 1040.11). These higher-power lasers have the potential for eye injury.
Consumers who purchased any of the 5,254 units of Galaxy Holiday Laser Lights and Northern Lights Holiday Laser Lights sold by Walmart between August 1, 2017 and October 25, 2017 should stop using them and return them to any Walmart store for a full refund.
The Galaxy Holiday Laser Lights and Northern Lights Holiday Laser Lights were manufactured from May through September 2017 and distributed from August through October 2017. The affected products sold by Walmart can be identified by the packaging photos and UPC numbers shown below.
Santajoy voluntarily recalled these products after becoming aware that the product presented a potential safety hazard and has notified the FDA of this action. There have been no reports of injury related to the use of these products. Santajoy is notifying the public through this press release, and Walmart is accepting the return of these products for a full refund.
Walmart Stores Inc. distributed these products nationwide. Consumers with questions may contact Walmart via telephone at 1-800-Walmart from 7 a.m. to 9 p.m. CT Monday through Friday or online at www.corporate.walmart.com/recalls for more information.
Note: As of January 1 2018, neither laser was listed on the Walmart Product Recalls webpage. The product recall also did not appear to be at FDA’s recalls webpage or enforcement report webpage, as of January 1. The only online source on that date was the December 22 2017 Business Wire press release, or a few publications and news sources such as KCTV that reprinted the Business Wire press release.
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...
Laserworld set up a special website, www.cdrh.info, with a statement and information from their viewpoint.
The International Laser Display Association published guidance for ILDA Members and others who are doing shows in the U.S. with Laserworld and RTI projectors.