BEUDAMED
    FDA Recall Terminated

    GE Healthcare Discovery IQ X-ray system

    Recall: Z-2192-2017 · Initiated May 19, 2017

    Recall

    Recall Number
    Z-2192-2017
    Event Number
    77377
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 19, 2017
    Terminated
    July 29, 2018
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Discovery IQ X-ray system

    Reason

    It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.

    Action

    GE Healthcare proposed action to bring defect into compliance : 1. Inform users of the potential for this issue to occur and instruct users as to the actions to take in the event of an Emergency Stop actuation during prep-delay. 2. Provide an update to product labeling for users that includes this information. GE Healthcare will include the updated product labeling with all current production systems. 3. Make modifications during the next scheduled product update to prevent this "race" condition from occurring in newly produced systems. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. Any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge. 3.You complete this recall by September 1, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. For further questions, please call (262) 513-4122.

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.

    Quantity

    10,884