Z-2435-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 15, 2021
- Initiation Date
- July 20, 2021
- Termination Date
- April 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,999 units
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.
Distribution Pattern
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.
Code Information
All serial numbers between NKV5502019xxxx - NKV5502112xxxx and the following serial numbers below: NKV55019270055, NKV55019370098R, NKV55019430125R, NKV55019470156R, NKV55019470160, NKV55020130200, NKV55020140213R, NKV55020140226R, NKV55020140229, NKV55020150241, NKV55020150252, NKV55020160268, NKV55020160276, NKV55020160277, NKV55020160292R, NKV55020160296, NKV55020160297, NKV55020160304, NKV55020160307, NKV55020160308, NKV55020160310, NKV55020160312, NKV55020170317, NKV55020170318, NKV55020170325, NKV55020170335, NKV55020170336, NKV55020170341, NKV55020170342, NKV55020170343, NKV55020170346, NKV55020170347, NKV55020170349, NKV55020170350, NKV55020170352, NKV55020170354, NKV55020170357, NKV55020170360, NKV55020180365, NKV55020180366, NKV55020180369, NKV55020180370, NKV55020180371, NKV55020180372, NKV55020180373, NKV55020180374, NKV55020180375, NKV55020180376, NKV55020180378, NKV55020180379, NKV55020180381, NKV55020180383, NKV55020180384, NKV55020180385, NKV55020180387, NKV55020180391, NKV55020180392, NKV55020180396, NKV55020180397, NKV55020180398, NKV55020180399, NKV55020180400, NKV55020180401, NKV55020180402, NKV55020180403, NKV55020180405, NKV55020180406, NKV55020180408, NKV55020180409, NKV55020180410, NKV55020180411, NKV55020180412, NKV55020180413