BEUDAMED
    FDA Recall Open, Classified

    Soltive Premium SuperPulsed Laser System, Model TFL-PLS

    Recall: Z-2504-2024 · Initiated May 31, 2024

    Recall

    Recall Number
    Z-2504-2024
    Event Number
    94964
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GEX
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    May 31, 2024
    Posted
    August 5, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Soltive Premium SuperPulsed Laser System, Model TFL-PLS

    Reason

    Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

    Action

    On 06/28/2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions Required: Our records indicate that your facility has purchased one or more of these products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Inspect your inventory and identify any devices with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 3. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the Soltive Laser System Instructions for Use, including instructions related to connecting the wireless footswitch. 4. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0448 c. Complete the form as instructed and include your account ID number. d. Indicate in the comments if your facility does not have a wired footswitch. Olympus Customer Service will contact you to make arrangements for a wired footswitch. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including failure of the wireless footswitch pairing with the Soltive Laser System, or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 from Monday through Friday or by e-mail [email protected].

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.

    Quantity

    1,585 Units