BEUDAMED
    FDA Recall Terminated

    AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.

    Recall: Z-2829-2016 · Initiated August 4, 2016

    Recall

    Recall Number
    Z-2829-2016
    Event Number
    74963
    Firm
    AirStrip Technologies, Inc.
    FEI Number
    3010608577
    Product Code
    LQK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 4, 2016
    Posted
    September 15, 2016
    Terminated
    November 30, 2016
    Address
    565 Pearl St, Ste 209, La Jolla, CA, 92037-5050

    Description

    AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.

    Reason

    Belt clip may become detached causing electronic components to be exposed.

    Action

    The firm sent out customer notification letters on August 4, 2016. Customers were instructed to cease distribution and use of the device and notify any customers in possession of it. Customers were informed that Airstrip would make arrangements to return the affected Central Units to AirStrip for correction at AirStrips expense. If customers have not been contacted by AirStrip to make these arrangements call AirStrip tollfree at 1 (877) 258-5869. For further questions, please call (210) 805-0444.

    Distribution

    U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.

    Quantity

    42