Recall Z-2435-2021— NIHON KOHDEN ORANGEMED, INC
Class II · Terminated
Class II FDA medical device recall by NIHON KOHDEN ORANGEMED, INC, initiated 2021-07-20, terminated 2023-04-21. It names 2 FDA 510(k) clearances: K192307, K181695. Product: Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.. Reason: Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use..
- Recalling firm
- NIHON KOHDEN ORANGEMED, INC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-20
- Terminated
- 2023-04-21
- Firm location
- Santa Ana, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K192307 — Nihon Kohden NKV-550 Series Ventilator System
- K181695 — Nihon Kohden NKV-550 Series Ventilator System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.
Reason for recall
Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.