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Monica
MONICA HEALTHCARE LIMITED · Model 105-PT-103 · UDI-DI 05060433670107
OSP
Prescription
10
510(k) clearances
9
Adverse events (3 deaths)
3
Recalls
10
Facilities
Description
Monica Interface CTG Cable - GE Corometrics FECG green rectangular connector
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. |
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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.