BEUDAMED
    FDA Enforcement Class II Ongoing

    Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

    Recall: Z-0908-2023 · Reported January 18, 2023

    Enforcement

    Recall Number
    Z-0908-2023
    Event ID
    91220
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Philips North America Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2023
    Initiation Date
    November 21, 2022
    Classification Date
    January 6, 2023
    Address
    222 Jacobs St, Cambridge, MA, 02141-2289, United States

    Description

    Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 989803137631

    Reason

    Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.

    Code Info

    UDI: (01)20884838007431. All devices shipped to and received by the customer from Philips between May 2020 until end Nov 2022

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Canada, China, Croatia, Cura¿ao, Czechia, Denmark, Faroe Islands, Finland, France, Germany, Hong Kong, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Oman, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Tanzania, United Republic Trinidad and Tabago, United Arab Emerates, United Kingdom.

    Quantity

    69,679 cases (1,741,975 units)