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NIHON KOHDEN ORANGEMED, INC recalls Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Vent
Recalled September 15, 2021 · FDA recall Z-2435-2021 · NIHON KOHDEN ORANGEMED
Hazard
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. · FDA Class II
Units
1,999 units
Sold at
Worldwide Distribution: US (nationwide) to states of: AZ, CA, NY, MA, VT, LA, DC, PA, FL, UT and OUS (countries) of: Brazil, Japan, Ireland, Poland, Scotland, Germany, Kazakhstan, Spain, Slovenia, Germany/Bulgaria, Russia, India, Palestine, Libya, Jordan Kuwait, Lebanon, Syria, Turkey, South Africa, United Arab Emirates, Mexico, Colombia, Peru, Costa Rica, Barbados, Ecuador, Bahamas, Bolivia, St Kitts & Nevis, St. Martin, Chile, Thailand, Laos, Philippines, Malaysia, Nepal and United Kingdom.
Description
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.
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.
Manufacturer(s)
NIHON KOHDEN ORANGEMED, INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →