BEUDAMED
    FDA Recall Open, Classified

    Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)

    Recall: Z-2661-2023 · Initiated August 10, 2023

    Recall

    Recall Number
    Z-2661-2023
    Event Number
    92893
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    JAK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 10, 2023
    Posted
    September 29, 2023
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx INS-5610 SPiN Perc Localization Needle - 1cm, 5/Bx INS-5600 SPiN Perc Biopsy Needle Guide Kit, 5/Bx (includes INS-5029)

    Reason

    Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

    Action

    Olympus Corporation of the Americas ( Olympus ),[Veran Medical Technologies, a wholly owned subsidiary] issued Urgent Medical Device Recall Letter on 8/10/23 to: Endoscopy Department, Pulmonary Department, Risk Management for the VERAN ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments. Letter states reason for recall, health risk and action to take: Veran requests you to take the following actions: 1. Inspect your inventory and identify any Veran models. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Call your Olympus customer service representative at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge. Your Olympus Customer Service representative will advise you on reimbursement for your Veran devices. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0430 4. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. If you require additional information, please contact Tara Safi, Field Corrective Actions Administrator at [email protected].

    Distribution

    Worldwide distribution - US Nationwide and the countries of CN, DE, HK, IT, KR, SG, TH, TW.

    Quantity

    9961 units