BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 26, 2025

    Recall

    Recall Number
    Z-0410-2026
    Event Number
    97707
    Firm
    Medistim Asa Okernveien
    FEI Number
    3010790133
    Product Code
    DPW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 26, 2025
    Posted
    October 29, 2025
    Address
    94 Oslo 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.

    Action

    Firm notified impacted consignees by email on September 26, 2025. Consignees were informed that qualified service personnel will perform the correction of the device according to the standard service procedure.

    Distribution

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

    Quantity

    14