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Respiratory Mechanics Sensor – Neonatal

DRAEGER MEDICAL SYSTEMS, INC. · Model 5957100 · UDI-DI 04049098007771

BZC
10
510(k) clearances
67
Adverse events
5
Recalls
33
Facilities

Recalls

DateFirmReason
2024-04-08Vyaire Medical, Inc.Potential of the nozzle separating during patient use.
2016-05-13Innovision A/SThe purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvani
2009-11-19Philips Healthcare Inc.Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical de
2009-11-19Philips Healthcare Inc.Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical de
2009-11-19Philips Healthcare Inc.Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical de

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Data 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.