Recall Z-2829-2016— AirStrip Technologies, Inc.
Class II · Terminated
Class II FDA medical device recall by AirStrip Technologies, Inc., initiated 2016-08-04, terminated 2016-11-30. It names one FDA 510(k) clearance: K143114. 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.. Reason: Belt clip may become detached causing electronic components to be exposed..
- Recalling firm
- AirStrip Technologies, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-04
- Terminated
- 2016-11-30
- Firm location
- La Jolla, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Belt clip may become detached causing electronic components to be exposed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.