BEUDAMED
    FDA Recall Terminated

    Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

    Recall: Z-1730-2014 · Initiated April 16, 2014

    Recall

    Recall Number
    Z-1730-2014
    Event Number
    68142
    Firm
    Maquet Medical Systems USA
    FEI Number
    3008355164
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 16, 2014
    Posted
    June 6, 2014
    Terminated
    April 6, 2016
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

    Reason

    Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach.

    Action

    Maquet issued "Urgent-Medical Device Field Correction" notices, dated April 16, 2014 to affected customers via Federal Express. The notice identified the product, related issue and the action needed to be taken by the customer. The corrective action will include inspection of the fixation tabs of the Ambient Light Module adn replacement of the Ambient Light Module if tabs are found to be defective. The correction will be performed by an authorized MAQUET Service Technician. MAQUET Service Team representatives will schedule on-site service with customers. If customers have any questions or require additional information, the notice instructs them to contact their local MAQUET representative, or MAQUET Customer Service at 1-888-627-8383 (option 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.

    Distribution

    US Nationwide Distribution.

    Quantity

    United States 1169 units