BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 1, 2022

    Recall

    Recall Number
    Z-1351-2022
    Event Number
    90364
    Firm
    Spectranetics Corporation
    FEI Number
    3007284006
    Product Code
    LPC
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 1, 2022
    Address
    9965 Federal Dr, Colorado Springs, CO, 80921-3822

    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.

    Action

    On June 08, 2022 Spectranetics issued a "Urgent Medical Device Correction" notification to affected consignees via USPS. The recall notification asked consignees to take the following actions: 1. Philips internal testing confirms that 1-3 reboots of the system will temporarily resolve the issue. Philips also recommends the continued use of the Philips Laser System, and to follow the Operator s Manual, as there is no expected harm to the user or patient. Philips recommends notifying all Philips Laser System users within your facility of this communication and retain a copy of this letter for reference. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form, included with this letter, within 30 days upon receipt of this notice to the following Email: [email protected] If you are a distributor or have forwarded affected device(s) to another end user, it is imperative that all end-users with affected devices receive this URGENT Medical Device Correction. Therefore, send a copy of this notification to any customer to whom you have distributed the affected product. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips IGTD Customer Service: Philips Laser System (PLS) Customer Service: Phone: 1-800-231-0978 Email: [email protected] Hours of Operation: Monday - Friday 9:00AM 5:00PM MST

    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