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Frontier X Plus
FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED · Model Frontier X Plus · UDI-DI 08908013617128
1
510(k) clearances
23
Adverse events (2 deaths)
2
Recalls
31
Facilities
Description
Single-lead ECG monitor intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-11 | Baxter Healthcare Corporation | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System |
| 2024-10-11 | Baxter Healthcare Corporation | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System |
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