BEUDAMED
    FDA Enforcement Class II Terminated

    VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.

    Recall: Z-2502-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2502-2018
    Event ID
    80452
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet SAS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    June 14, 2018
    Classification Date
    July 19, 2018
    Termination Date
    June 23, 2022
    Address
    Parc De Limere, Avenue De La Pomme De Pin, Orleans, N/A, France

    Description

    VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgical lights are designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. StandOP VOLISTA is a system of ceiling-mounted surgical lights suited for installation in surgical suites, examining rooms, doctors surgeries and out-patient consultations.

    Reason

    Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affected device may result in serious injury to patient and/or medical staff if the light head detaches and drops, impacting patient and/or medical staff during demonstration, service, or use.

    Code Info

    All Serial Numbers manufactured from March 10, 2014 until November 17, 2016 6.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, KS, KY, LA, MD, ME, MO, NE, NY, OH, OR, TN, TX, UT, and WA. Foreign distribution to Argentina, Australia, Austria, Bangladesh, 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, Ireland, Italy, Japan, Jordan, Kenya, Korea, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Namibia, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Poland, Portugal, South Korea, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Tanzania, Yemen, and Zimbabwe.

    Quantity

    151