BEUDAMED
    FDA Recall Terminated

    SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.

    Recall: Z-0781-2007 · Initiated January 19, 2007

    Recall

    Recall Number
    Z-0781-2007
    Event Number
    37819
    Firm
    Smith & Nephew, Inc Endoscopy Division
    FEI Number
    1643264
    Product Code
    FWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 19, 2007
    Posted
    May 5, 2007
    Terminated
    September 2, 2008
    Address
    76 S. Meridian Ave, Oklahoma City, OK, 73107-6512

    Description

    SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.

    Reason

    Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)

    Action

    Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return.

    Distribution

    Foreign Distribution Only-No U. S. A. distribution International distribution to: Argentina, Austria, Australia, Belgium, Brazil, China, Columbia, Denmark, Dubai, France, Germany, Greece, Italy, India, Japan, Korea, Malaysia, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Turkey and United Kingdom.

    Quantity

    77 units.