BEUDAMED
    FDA Recall Terminated

    Visum LED Surgical Lights/ Visum Halogen Surgical Lights. Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 Visum LED Surgical Lights and Visum Halogen Surgical Lights are ceiling mounted devices which provide illumination via LED lights and halogen bulbs. All systems are ceiling or wall mounted lights and each provides sufficient illumination with high intensity light for all types of surgical procedures.

    Recall: Z-0137-2012 · Initiated August 23, 2011

    Recall

    Recall Number
    Z-0137-2012
    Event Number
    59866
    Firm
    Stryker Communications Corp
    FEI Number
    3002975342
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 23, 2011
    Posted
    October 28, 2011
    Terminated
    August 20, 2012
    Address
    1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

    Description

    Visum LED Surgical Lights/ Visum Halogen Surgical Lights. Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 Visum LED Surgical Lights and Visum Halogen Surgical Lights are ceiling mounted devices which provide illumination via LED lights and halogen bulbs. All systems are ceiling or wall mounted lights and each provides sufficient illumination with high intensity light for all types of surgical procedures.

    Reason

    Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.

    Action

    Stryker sent an URGENT FIELD SAFETY NOTICE: RA2010-245 dated August 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Customer Response Form within 5 business days to Stryker. A Stryker representative would contact them at their convenience to schedule a re-inspection for all of the units identified and still in use. In the event the inspected equipment does not meet Stryker's established specifications, their representative will visit their facility and hopefully resolve the issue. If a subsequent visit is required the date will be scheduled in full consideration of their services. For questions regarding this recall call 972-410-7310.

    Distribution

    Worldwide Distribution including Puerto Rico, Brazil, Ecuador, Venezuela, Costa Rico, Bolivia, Peru, Mexico, China, India, Korea, Philippines, Singapore, Malaysia, Taiwan, Middle East, Russia, Africa, Poland, South Africa, Australia, New Zealand, Canada, Japan, Denmark, Finland, Norway, Sweden, Belgium, The Netherlands, France, Germany, Austria, Italy, Portugal, Spain, Romania, Switzerland, and United Kingdom.