Power Over Fiber Base Module

Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized quality control procedures and record keeping of QC testing was not performed to IEC 60825-1 nor 21 CFR 1040.10 standards. Sales information did not convey required class designation and warning statement

A letter was received stating the product, problem and actions to be taken. The following actions being taken include: A. Develop and carry out a process to remove incorrect labeling and install all labels required under IEC 60825-1 2014. B. Generate, detail & submit full CAP (Corrective Action Plan) for FDA approval C. Generate initial laser product report or supplemental as appropriate. D. Equipment update to be performed by Terex personnel at customer location E. Procedures: * Fully certify device as Class 1 under the guidelines of FDA Laser Notice #56 by applying the IEC 60825-1 2014 laser certification standard * Update and distribute compliant UI (User Information) * Update Sales information as appropriate * Generate and apply administrative and safety labeling * Formalized quality control procedures and record keeping. If you have any questions, contact Director of Engineering at +16058824000 or email: [email protected]