BEUDAMED
    FDA Recall Open, Classified

    IntelliBridge EC10 Module. Model Number: 865115

    Recall: Z-1106-2025 · Initiated January 15, 2025

    Recall

    Recall Number
    Z-1106-2025
    Event Number
    96138
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    January 15, 2025
    Posted
    February 5, 2025
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    IntelliBridge EC10 Module. Model Number: 865115

    Reason

    Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

    Action

    Philips began notifying consignees on about 01/15/2025 via certified letters titled URGENT Field Safety Notice and URGENT Medical Device Correction letters. Consignees were instructed to ensure that there is no interruption of the cable connection between the Hamilton ventilator and the EC10 Module or IntelliBridge I/O board before use, provide the notification to all affected personnel and customers if the devices have been further distributed, and to complete and return the response form provided. A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will upgrade your ED245 Driver from revision A.0 to revision A.1. Distributors were instructed to return the Response Form attached your contact information, send the attached URGENT Field Safety Notice to each customer to whom you have distributed any affected device as soon as possible and no later than 5 days, together with the Reply Card, perform a good faith effort to get the Response Form by following up with the customer with a minimum of three attempts, and if possible, using multiple contact methods, inform Philips about the responses received, and implement the Technical solution established by Philips as soon as available within the timeframe communicated by Philips and confirm to Philips the implementation in all affected products. In case a product is not corrected, inform Philips on the reason why the technical solution cannot be implemented.

    Distribution

    US distribution to Florida, North Carolina, and Oregan. International distribution to Canada, Estonia, France, Germany, Japan, Netherlands, Spain, Switzerland, United Kingdom.

    Quantity

    2,230 units