BEUDAMED
    FDA Recall Open, Classified

    MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

    Recall: Z-0004-2023 · Initiated September 6, 2022

    Recall

    Recall Number
    Z-0004-2023
    Event Number
    90857
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    MWI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 6, 2022
    Posted
    October 4, 2022
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

    Reason

    Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.

    Action

    On September 6, 2022, Philips notified affected customers through URGENT Medical Device Recall letters. A Philips representative will contact customers to arrange a software update. once arranged, a Philips representative will conduct a software update on the device for the customer. Customers should share the recall information with all clinical staff to review and understand. The notice should be placed with the documentation of the MR Patient Care Portal 5000.

    Distribution

    Domestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA SC TN TX UT VT WA WY. Foreign distribution to Australia Austria Belgium Czech Republic Denmark Estonia Finland France Germany Ireland Italy Malta Netherlands Norway Poland Portugal Qatar Singapore Slovakia Spain Sweden Switzerland United Kingdom

    Quantity

    115 US; 193 ROW