BEUDAMED
    FDA Recall Open, Classified

    wDR 2.2 Mobile Digital Diagnostic X-Ray System

    Recall: Z-2045-2023 · Initiated May 23, 2023

    Recall

    Recall Number
    Z-2045-2023
    Event Number
    92464
    Firm
    SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain
    FEI Number
    3002495042
    Product Code
    IZL
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    May 23, 2023
    Posted
    June 30, 2023

    Description

    wDR 2.2 Mobile Digital Diagnostic X-Ray System

    Reason

    There is a software login in issue that may prevent the user from logging in.

    Action

    A recall notification letter was mailed to customers in the United States by the US distributor, Philips, beginning May 23, 2023. Customers are advised to take the following actions: 1) To prevent the system from becoming inoperable, do not reboot or log out of your system until Philips has implemented the software correction. 2) Circulate this notice to all users of the device so that they are aware of the issue. 3) Complete and return the response form to Philips promptly and no later than 30 days from receipt. A Philips representative will contact consignees to schedule a time for a Field Service Engineer to visit the site and implement a software solution to resolve the issue.

    Distribution

    Distribution throughout United States including Puerto Rico and US Virgin Islands OUS distribution to Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Hungary, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia,Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam, and Zambia

    Quantity

    1061 units