BEUDAMED
    FDA Recall Open, Classified

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    Recall: Z-1661-2026 · Initiated March 3, 2026

    Recall

    Recall Number
    Z-1661-2026
    Event Number
    98434
    Firm
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis
    FEI Number
    3042175844
    Product Code
    OWB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 3, 2026
    Posted
    March 27, 2026
    Address
    6 Best Netherlands

    Description

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

    Reason

    Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

    Action

    On March 3, 2026, URGENT Medical Device Correction letters were sent to customers. Actions to be taken: 1. Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue and follow the instructions below. 2. Perform the daily check before starting the first procedure, as described in the device labelling 3. Should you experience a foot switch activation issue, please report it to your local Philips representative. 4. In case the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through your local Philips representative. 5. Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. 6. Complete and return the response form included in this Urgent Medical Device Correction letter to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken.

    Distribution

    Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkiye, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen;

    Quantity

    2291 units (493 US, 1798 OUS)