Home › Device types › NOU
Continuous, Ventilator, Home Use
FDA product code NOU · Class 2 · Anesthesiology
357
Registered devices
6,912
Adverse events
16
Recalls
7
510(k) clearances
Devices with this code
VOCSN Patient Breathing Package — Ventec Life Systems, Inc.Trilogy — Respironics, Inc.Garbin — Respironics, Inc.Care Orchestrator — Respironics, Inc.Care Orchestrator — Respironics, Inc.Vivo 65 — Breas Medical ABVivo 45 LS — Breas Medical ABTrilogy 200 — Respironics, Inc.Trilogy Evo — Respironics, Inc.Trilogy Evo — Respironics, Inc.Sensor — Respironics, Inc.Patient Circuit — FLIGHT MEDICAL INNOVATIONS LTDCare Orchestrator — Respironics, Inc.Patient Circuit — FLIGHT MEDICAL INNOVATIONS LTDTrilogy 200 — Respironics, Inc.Trilogy 200 — Respironics, Inc.Care Orchestrator — Respironics, Inc.External Pulse Oximeter (Nonin XPOD) — Respironics, Inc.Vivo 45 LS, Vivo 65 — Breas Medical ABVivo 50 — Breas Medical ABTrilogy Evo — Respironics, Inc.VOCSN Patient Breathing Package — Ventec Life Systems, Inc.Patient Circuit — FLIGHT MEDICAL INNOVATIONS LTDVOCSN Patient Breathing Package — Ventec Life Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-25 | Ventec Life Systems, Inc. | Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions durin |
| 2024-07-25 | Breas Medical, Inc. | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. |
| 2024-07-16 | Philips Respironics, Inc. | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identi |
| 2024-07-16 | Philips Respironics, Inc. | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identi |
| 2023-10-13 | Breas Medical, Inc. | Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV a |
| 2022-06-02 | Breas Medical, Inc. | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator depende |
| 2021-07-26 | Philips Respironics, Inc. | Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure |
| 2021-07-26 | Philips Respironics, Inc. | Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure |
| 2021-07-26 | Philips Respironics, Inc. | Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure |
| 2020-01-28 | Breas Medical, Inc. | The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. |
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