BEUDAMED
    FDA Enforcement Class II Terminated

    AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

    Recall: Z-1393-2019 · Reported May 29, 2019

    Enforcement

    Recall Number
    Z-1393-2019
    Event ID
    82691
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2019
    Initiation Date
    April 8, 2019
    Classification Date
    May 22, 2019
    Termination Date
    May 10, 2023
    Address
    300 Boston Scientific Way, N/A, Marlborough, MA, 01752-1291, United States

    Description

    AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.

    Reason

    Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message.

    Code Info

    Serial Number: 21302939, 21302937, 21302938

    Distribution

    Worldwide distribution to Australia, Belgium, Brazil, Chile, Colombia, Egypt, France, Germany, Great Britain, India, Indonesia, Iran, Italy, Lebanon, Malaysia, Mexico, Romania, Russia Fed., South Africa, South Korea, Spain, Taiwan, United Arab Emirates and Vietnam

    Quantity

    3 (OUS)