BEUDAMED
    FDA Recall Open, Classified

    EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation

    Recall: Z-0056-2025 · Initiated September 14, 2023

    Recall

    Recall Number
    Z-0056-2025
    Event Number
    93217
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FDF
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 14, 2023
    Posted
    October 11, 2024
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation

    Reason

    Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.

    Action

    An URGENT: MEDICAL DEVICE FIELD CORRECTIVE ACTION notification letter dated 9/14/23 was sent to customers. Action steps to be taken by the end user: Olympus has determined based upon our distribution records that your facility is in possession of one or more affected CV-190 with a serial number shown in Attachment 1. Olympus requires that you take the following actions: 1. Inspect your inventory for the referenced products and identify any devices with the model number and serial number specified in Attachment 1. Cease use of products and quarantine any affected products. Please check all areas of the hospital to determine if any of these products remain in inventory. 2. Please contact our Olympus Repair Center at 1-800-848-9024, option 3, to arrange for a service to exchange the power supply unit in affected devices. Olympus regrets any inconvenience caused and fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me at 647-999-3203 or [email protected].

    Distribution

    US Nationwide distribution.

    Quantity

    45 units