Device recall
Z-2829-2016: AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is…
FDA device recall · Class II · AirStrip Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-2829-2016 |
|---|---|
| Recall event | 74963 |
| 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… |
| Product code | LQK |
| Recalling firm | AirStrip Technologies, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 30, 2016 |
| 510(k) numbers | K143114 |
| FEI number | 3010608577 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database