BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM

    Recall: Z-1351-2022 · Reported July 20, 2022

    Enforcement

    Recall Number
    Z-1351-2022
    Event ID
    90364
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Spectranetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 20, 2022
    Initiation Date
    June 1, 2022
    Classification Date
    July 11, 2022
    Address
    9965 Federal Dr, Colorado Springs, CO, 80921-3822, United States

    Description

    Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle dependent upon device in use 100 - 240 VAC, 50/60HZ, 16 AM

    Reason

    The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.

    Code Info

    Serial Numbers: 100000 to 100104 UDI/DI: (01)00813132027452

    Distribution

    US: AR AZ CA CO CT FL GA HI IA IL IN KS LA MA MD ME MI MN MO NC NJ NY OK PA TN TX VA OUS: Saudi Arabia, Denmark, France, Greece, India, Italy, Netherlands, Serbia, Spain, Sweden, United Kingdom

    Quantity

    105 units