AirStrip Technologies, Inc. recalls AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fe…

Recall date

August 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2829-2016

FDA classification

Class II

Brand / firm

AirStrip Technologies, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.