BEUDAMED
    FDA Recall Terminated

    Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

    Recall: Z-1965-2019 · Initiated July 2, 2019

    Recall

    Recall Number
    Z-1965-2019
    Event Number
    83271
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 2, 2019
    Posted
    July 12, 2019
    Terminated
    October 5, 2020
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Repair RIC5-9A-RS System, imaging, pulsed doppler, ultrasonic and Refurbish RIC-5-9-D REALTIME 4D

    Reason

    Potential for a transducer mis-alignment in certain transvaginal probes.

    Action

    GE Healthcare notified customers on about 07/02/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that they could continue to use the affected probes, but prior to performing a biopsy, customers should make sure they follow the instructions for safe use in the Basic User Manual to ensure proper device alignment, specifically including the biopsy, biopsy safety and biopsy setup sections. GE Healthcare will correct all affected devices at no cost and a GE Healthcare representative will contact customers to arrange for the correction. Customers were also instructed to complete and return the Medical Device Notification Acknowledgement Response form. Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    Distribution in the US to Texas. International distribution to France, Greece and Switzerland.

    Quantity

    2 devices