AirStrip Sense4Baby Fetal Monitor Recalled for Detaching Belt Clip
AirStrip Technologies is recalling 42 Sense4Baby Model C fetal monitors because the belt clip may detach, exposing electronic components.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential exposure to electronic components without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
AirStrip Technologies, Inc. is recalling 42 units of the AirStrip Sense4Baby Model C Fetal Monitor. The recall was initiated because the belt clip on the device may become detached, which could cause the internal electronic components to be exposed.
The Sense4Baby System Model C is indicated for monitoring maternal and fetal physiologic parameters during the antepartum period. The device is intended for use 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. Data interpretation is to be done by a health care professional.
The affected units were distributed in the United States to Arkansas and Louisiana, and internationally to South Africa and the Netherlands. Specific serial numbers for the recalled units are listed in the official recall documentation.
The recalled product
- 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…
- Manufacturer
- AirStrip Technologies, Inc.
- Category
- Medical Device — Fetal Monitor
- Hazard
- Affected units
- 42
Distribution
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