BEUDAMED
    FDA Recall Terminated

    Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810.

    Recall: Z-0840-2007 · Initiated April 9, 2007

    Recall

    Recall Number
    Z-0840-2007
    Event Number
    37849
    Firm
    Smith & Nephew, Inc Endoscopy Division
    FEI Number
    1643264
    Product Code
    FFS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 9, 2007
    Posted
    June 7, 2007
    Terminated
    September 2, 2008
    Address
    76 S. Meridian Ave, Oklahoma City, OK, 73107-6512

    Description

    Smith & Nephew, 420XL Xenon Light Source, 180 Watt; for endoscopic use. Catalog/Part #72200510; manufactured for Smith & Nephew Endoscopy, Andover, MA 01810.

    Reason

    Several units were manufactured using a power supply that contains a 1 amp fuse where a 5 amp fuse is required. When the unit's power supply draws more that 1A, the fuse will fail causing the light to cease operating. The problem can occur anytime: from the initial turning on (powering up), to anytime during use.

    Action

    Notification sent 04/09/07 via FedEx to distribution centers, sales reps and user facilities. Users asked to send light source to Smith & Nephew GMBH Service Center in Germany for repair (contact Ute Dieling at +49 (0) 7462-208-313).

    Distribution

    Product sent to distributors in Argentina, Austria, Chile, Denmark, Dubai, France, Greece, Hong Kong, India, Italy, Japan, Korea, Malaysia, Norway, South Africa, Spain, Sweden and United Kingdom. No US distribution.

    Quantity

    67 units.