Home › O.B - TOOLS LTD › EmbraceTM Electrodes Array (L)
EmbraceTM Electrodes Array (L)
O.B - TOOLS LTD · Model FG0003(X) · UDI-DI 07290016406030
10
510(k) clearances
9
Adverse events (3 deaths)
3
Recalls
10
Facilities
Description
Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-15 | GE Healthcare, LLC | if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displaye |
| 2017-12-15 | GE Healthcare, LLC | if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed |
| 2017-04-28 | MONICA HEALTHCARE LTD | Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.