Recall Z-2435-2021 ยท CBK Ventilator, Continuous, Facility Use
NIHON KOHDEN ORANGEMED, INC
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.
| Date | Jul 20, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm Nihon Kohden OrangeMed, Inc., sent an "URGENT-Medical Device Correction Recall Safety Notice" letter to its customers on July 26, 2021. The letter describes the product, issues and actions to be taken. The customers were instructed to do the following prior to actions being implemented by the manufacturer: 1. Pass this notice on to all those who need to be aware within your organization and to any organization where the affected devices have been transferred. 2. Perform Device Check and Circuit Check as instructed in the NKV-550 ventilator Operator s Manual. A defective regulator can |
| Quantity | 1,999 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |