BEUDAMED
    FDA Recall Open, Classified

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    Recall: Z-1786-2022 · Initiated August 31, 2022

    Recall

    Recall Number
    Z-1786-2022
    Event Number
    90839
    Firm
    Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia
    FEI Number
    3012855798
    Product Code
    IZL
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 31, 2022
    Posted
    September 23, 2022

    Description

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    Reason

    Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions

    Action

    On or about 09/31/2022, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via email/telephone to customers informing them that during an internal data analysis on 08/18/2022, Micro-X Ltd identified software calibration errors with the product equipped with a Dose Area Product (DAP) meter. This resulted in the product displaying incorrect DAP meter values. The DICOM image produced by the system will report a DAP measurement in microgray/square meter that is 8 to 10 times lower than the actual dose delivered. Customers are instructed to: 1. Inspect their stock immediately and place the Recall Notification Letter on the affected product and quarantine affected product on hand to prevent further use. 2. Contact the nominated Service representative to arrange the re-calibration of the DAP Meter. Email: [email protected] or Phone 1-206-249-8764. 3.Previous version of Service Documentation (ROV208-2 Acceptance and Compliance Testing Instructions) which includes inaccurate DAP calibration processes are to be removed from use. 4. Complete and return Acknowledgement and Receipt Form immediately to Micro-X LTD in Australia: [email protected] and copy [email protected] 5. Ensure relevant staff members are informed of the Recall and if affected units have been supplied/transferred to another facility, inform them immediately. For question or further assistance, contact Regulatory Affairs Manager at [email protected]

    Distribution

    Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of Australia, France, Israel, Japan, and United Arab Emirates.

    Quantity

    42 units