BEUDAMED
    FDA Recall Open, Classified

    CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

    Recall: Z-1828-2026 · Initiated March 6, 2026

    Recall

    Recall Number
    Z-1828-2026
    Event Number
    98476
    Firm
    Integra LifeSciences Corp. (NeuroSciences)
    FEI Number
    3003418325
    Product Code
    LFL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 6, 2026
    Posted
    April 17, 2026
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650

    Description

    CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.

    Reason

    Software issue that renders the touch screen unresponsive.

    Action

    An URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION notice dated 3/6/26 was sent to consignees. The notice instructs consignees to restart systems when freeze to restore functionality of the touchscreen capabilities for 8 minutes; this action may be used multiple times. Integra's Service and Repair can provide remote support to disable and re-enable the write filter with Integra employees and/or Authorized service personnel. This will reset the console to provide approximately 28 days with no touchscreen issue. Integra Lifesciences Service Team will contact consignees within 5 to 10 business days to schedule correction of affected devices at no cost. Consignees with any questions can direct them to Customer Service by emailing [email protected] or by phone at 1-800-654-2873.

    Distribution

    Worldwide - US Nationwide distribution in the states of MI & NY. The countries of Belgium, China, Czechia, Dubai, Finland, France, Germany, Italy, Japan, Luxembourg, Netherlands. Poland, Spain, Switzerland, Tunisia & United Kingdom.

    Quantity

    78 units