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AirStrip Technologies, Inc. recalls AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and
Recalled September 21, 2016 · FDA recall Z-2829-2016 · AirStrip Technologies
Hazard
Belt clip may become detached causing electronic components to be exposed. · FDA Class II
Units
42
Sold at
U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.
Description
Belt clip may become detached causing electronic components to be exposed.
Product
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.
Manufacturer(s)
AirStrip Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →