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Recall Observatory FDA recall evidence

Device 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.

Z-2829-2016

August 04, 2016

Class II

Product summary

Firm
AirStrip Technologies, Inc.
Event
Event 74963
Status
Terminated
Classification
Class II
Quantity
42
Official record key
device-enforcement:Z-2829-2016

Official wording

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

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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