BEUDAMED
    FDA Recall Open, Classified

    Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.

    Recall: Z-2579-2026 · Initiated June 5, 2026

    Recall

    Recall Number
    Z-2579-2026
    Event Number
    99126
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    MHX
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 5, 2026
    Posted
    June 24, 2026
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.

    Reason

    Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.

    Action

    Philips Medical notified consignees on about 06/05/2026 via "URGENT Medical Device Correction" letter. Consignees were notified of the issue and potential hazard and instructed to continue the use of the device but avoid touching the display while the device is booting up and provide this notification to all personnel who need to be aware within each organization or to any organization where affected product(s) have been potentially transferred. Philips will release new software which will correct this problem. A Philips representative will contact you to arrange for an upgrade to the new software.

    Distribution

    US Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA, SD, TN.

    Quantity

    909 units