BEUDAMED
    FDA Recall Open, Classified

    Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

    Recall: Z-2523-2026 · Initiated May 26, 2026

    Recall

    Recall Number
    Z-2523-2026
    Event Number
    99084
    Firm
    Philips North America Llc
    FEI Number
    3016618143
    Product Code
    HGM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 26, 2026
    Posted
    June 22, 2026
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289

    Description

    Philips Avalon Fetal Monitor, FM 30 Part numberM2703A

    Reason

    Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

    Action

    Philips issued an URGENT Medical Device Correction notice to its consignees on 5/26/2026 via USPS certified mail. The notice explained the issue and how it can be identified, potential risk to the patient should the loss of audio is not detected, and requested the following: "Actions that should be taken by the customer / user in order to prevent risks for patients or users " Ensure fetal heart rate tones are enabled on the Avalon Fetal Monitor until the planned fix/correction is implemented. " Pass this notice to all those who need to be aware within your organization or to any organization where affected product(s) have been potentially transferred. " Place this Urgent Medical Device Correction with the documentation of the Philips Avalon Fetal Monitor and associated devices in a place where it is most likely to be seen and viewed."

    Distribution

    Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA.

    Quantity

    169 units