BEUDAMED
    FDA Recall Terminated

    Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Numbers: LS7500, LS7500L (loaner), LS7500R (refurbished)

    Recall: Z-1531-05 · Initiated August 1, 2005

    Recall

    Recall Number
    Z-1531-05
    Event Number
    33059
    Firm
    Linvatec Imaging
    FEI Number
    1000125338
    Product Code
    GCT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 1, 2005
    Posted
    September 10, 2005
    Terminated
    April 16, 2012
    Address
    749 Ward Dr, Santa Barbara, CA, 93111-2918

    Description

    Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Numbers: LS7500, LS7500L (loaner), LS7500R (refurbished)

    Reason

    Through the complaint handling system, the company has determine there are performance issued involving the LS7500, 300 Watt Xenon Light Source. The performance issues result in a low light output that can create poor illumination of the surgical site.

    Distribution

    Nationwide and Australia, Belgium, Brazil, Canada, Chile, China, Denmark, France, Germany, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, and Venezuela.

    Quantity

    810 units