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BIS
Covidien LP · Model 186-0106-PH · UDI-DI 20884521134505
OLW
Prescription
3
510(k) clearances
361
Adverse events (1 deaths)
1
Recalls
35
Facilities
Description
Quatro Sensor Kit, (25) 186-0106
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.