FDA Medical Device Recalls (openFDA)
AirStrip Technologies, Inc.: 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 number
- Z-2829-2016
- Recalling firm
- AirStrip Technologies, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2016-08-04
- Posted
- 2016-09-15
- Terminated
- 2016-11-30
- Reason
- Belt clip may become detached causing electronic components to be exposed.
- Root cause
- Nonconforming Material/Component
- 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.
- Quantity
- 42
- Distribution
- U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.
- Lot, serial or model codes
- Serial Number: C2386DA70E C2386EC9CD C2386ECAF3 C2386EC9CE C2386EC9B6 C2386EC9C5 C2386EC9C0 C2386EC9CB C2386DA70D C2386EC9AF C2386EC9B7 C2386EC9CF C2386EC9B4 C2386DA718 C2386ECAF5 C2386EC9B5 C2387684D9 C2386DA771 C2386EC9B8 C2386EC9D4 C2386EC9C3 C2386EC9B3 C2386ECAFA C2386EC4C4 C2386EC9C9 C2386EC9D3 C2386ECAE6 C2386DA77E C2386EC9B1 C2386DA715 C2386EC9CE C2386EC9BC C2386ECB36 C2386EC9C1 C2386EC9DC C2386ECAF8 C2386DA786 C2386ECAFB C2386EC9AE C2386EC9C8 C2386EC9D0 C2386ECAEE
- 510(k) numbers
- ["K143114"]
- PMA numbers
- not on file
- Product code
- LQK
- Firm FEI
- 3010608577
- Firm city
- La Jolla
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28