BEUDAMED
    FDA Recall Terminated

    VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.

    Recall: Z-1349-2018 · Initiated February 7, 2018

    Recall

    Recall Number
    Z-1349-2018
    Event Number
    79583
    Firm
    GETINGE US SALES LLC
    FEI Number
    3012092534
    Product Code
    FSY
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 7, 2018
    Posted
    April 10, 2018
    Terminated
    September 2, 2021
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical suites, examining rooms, doctors' surgeries and outpatient consultations.

    Reason

    The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of such detachment, particles from the handle holder ring could fall into the sterile field during a procedure.

    Action

    The firm, Getinge, sent an "URGENT MEDICAL DEVICE RECALL" Notice dated 2/7/2018 to all affected consignees via mail. The notice described the product, problem and actions to be taken. The consignees were instructed to do the following: 1) Ensure that all users of the device are made aware of this field correction. 2) Check the device serial number against the list of affected serial numbers. 3) Contact the recalling firm to arrange for servicing of all affected units. Getinge Customer Service: (800) 950-9912, 8AM - 5PM (EST) Monday to Friday. 4) Complete and sign the enclosed customer response form, and return it by fax to: (973) 860-1675 or by email to: [email protected]. If you have any questions, please contact your Getinge representative or call Getinge Customer Service at (800)950-9912 (Select option 1) between 8:00 AM and 5:00 PM (EST).

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, ID, IA, KS, KY, ME, MO, NE, NY, OR, TN, TX, UT, and WA; and countries of: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Cameroon, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Ghana, Hong Kong, Hungary, India, Iran, Iraq, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad-Tobago, Turkey, UAE, UK, Yemen and Zimbabwe.

    Quantity

    5214