BEUDAMED
    FDA Recall Terminated

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF

    Recall: Z-1863-2019 · Initiated May 28, 2019

    Recall

    Recall Number
    Z-1863-2019
    Event Number
    82978
    Firm
    Maquet Cardiovascular Us Sales, Llc
    FEI Number
    3008355164
    Product Code
    FTD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 28, 2019
    Posted
    June 21, 2019
    Terminated
    July 10, 2023
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF

    Reason

    Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection

    Action

    Getinge/Maquet SAS issued on 5/28/19 Urgent Medical Correction letter via FedEx 2 day Delivery with Signature Proof of Delivery (SPOD). Letter provides identification of issue, health risk and action to take: Before using the VOLISTA StandOP, please inspect the forks and check if cracks on the coating are visible as instructed in the VOLISTA StandOP manual; If a coating crack is detected, please STOP USING the VOLISTA StandOP and contact your Getinge representative. Complete and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM . Return the completed form to Maquet/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to 1-707-202-7275;A Getinge Sales or Service representative will contact you to schedule inspection and correction if necessary of the VOLISTA StandOP SURGICAL LIGHTS at your facility. For technical questions, contact Technical Support Department at 1-888-627-8383 (press option 3 then option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. ***Updated 3/30/2020*** On March 30, 2020, the firm sent an new letter to customers, informing them of an update to the corrective actions previously communicated. The firm has developed an interim solution for affected devices. The solution consists of a validated adhesive strip that is resistant to mechanical stresses and compatible with typical chemical agents used in the operating rooms. The solution allows customers to continue using their lights until their defective forks are replaced. The interim solution will be applied by a Getinge representative. A Getinge Sales or Service representative will contact customers to schedule inspection and correction (if necessary) of affected devices at each facility. If your site has already been contacted to schedule an inspection, the work above will be performed during that scheduled visit.

    Distribution

    Worldwide distribution. US Nationwide, ALBANIA GHANA PORTUGAL ARGENTINA HONG KONG ROMANIA AUSTRIA HUNGARY RUSSIA AUSTRALIA INDIA SAUDI ARABIA AZERBAIJAN IRAN SINGAPORE BAHAMAS IRELAND SLOVAKIA BANGLADESH IRAQ SLOVENIA BELGIUM ISRAEL SOUTH AFRICA BOLIVIA ITALY SOUTH KOREA BRAZIL JAPAN SPAIN BULGARIA JORDAN SWEDEN CAMEROON LATVIA SWITZERLAND CANADA LEBANON TAIWAN CHILE LUXEMBOURG TANZANIA CHINA MALAYSIA THAILAND COLOMBIA MEXICO TRINIDAD and TOBAGO COSTA RICA MOLDAVA TURKEY CROATIA MOZAMBIQUE UNITED ARAB EMIRATES CUBA MYANMAR UNITED KINGDOM CZECH REPUBLIC NETHERLANDS VIETNAM DENMARK NAMIBIA VENEZUELA DOMINICAN REPUBLIC NIGERIA YEMEN ECUADOR NORWAY ZIMBABWE EGYPT NEW ZEALAND ESTONIA OMAN ESWATINI PAKISTAN FINLAND PANAMA FRANCE PARAGUAY GERMANY POLAND

    Quantity

    9 units