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RD Sedline
MASIMO CORPORATION · Model 4329 · UDI-DI 10843997012802
OLW
Prescription
1
510(k) clearances
330
Adverse events (1 deaths)
1
Recalls
36
Facilities
Description
RD Sedline EEG Sensor Pediatric
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-26 | Covidien LLC | Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems |
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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.