BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No

    Recall: Z-0410-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0410-2026
    Event ID
    97707
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medistim Asa
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 5, 2025
    Initiation Date
    September 26, 2025
    Classification Date
    October 29, 2025
    Address
    Okernveien 94, N/A, Oslo, N/A, N/A, Norway

    Description

    Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No

    Reason

    Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.

    Code Info

    Lot Code: Serial number; Model number 5042; MQC04001 5043; MQC04001 5044; MQC14001 5061; MQU14011 5062; MQU14011 5064; MQU14011 5065; MQU14011 5066; MQU14011 5067; MQC04001 5037; MQU14011 5073; MQV12011 5038; MQU14011 5045; MQU14011 5063; MQU14011

    Distribution

    Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.

    Quantity

    14