Nihon Kohden America Inc

Model Number: CNS-6201  Software Version 02-26 only. Serial Numbers: 00485,  00488,  00489,  00490,  00491,  00361,  00429,  00430, 00432,  00436,  00443,  00447,  00478,  00486,  00546,  00564,  00573,  00574,  00575,  00576,  00592,  00626, 00638, 00643,  00651,  00674,  00675,  00677,  00678, 00679, 00687.

Cardiovascular Devices

2

No

Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.

CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 || For cardiac and vital signs monitoring for multiple patients.

RNS-9703-019 Serial Number 2002 and higher RNS-9703-024 Serial Number 2002 and higher  Serial number 2040 2041 2042 2043 2044 2045 2014 2015 2016 2017 2030 2031 2060 2061 2062 2067 2068 2069 2070 2033 2095 2096 2097 2098 2029 2036 2039 2041 2042 2043 2044 2045 2046 2047 2048 2049 2123 2011 2012 2013 2022 2023 2024 2025 2026 2027 2028 2032 2037 2106 2037 2038 2010 2077 2078 2034 2035 2021 2022 2023 2024 2028 2029 2059 2060 2061 2062 2063 2002 2063 2064 2065 2105 2066 2006 2007 2099 2109 2110 2030 2031 2050 2051 2052 2053 2054 2055 2056 2057 2058 2032 2046 2047 2048 2049 2050 2051 2052 2053 2054 2055 2056 2057 2058 2059 2064 2065 2066 2067 2068 2069 2070 2071 2072 2073 2074 2075 2076 2077 2078 2079 2080 2081 2082 2083 2084 2085 2086 2087 2088 2089 2090 2091 2092 2093 2094 2095 2096 2097 2098 2099 2100 2101 2102 2103 2104 2100 2009 2111 2112 2113 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2071 2072 2073 2074 2075 2018 2019 2033 2034 2036 2101 2086 2087 2088 2089 2080 2081 2082 2083 2084 2085 2025 2026 2027 2038 2039 2021 2003 2004 2005 2020 2090 2091 2092 2093 2094 2008

Cardiovascular Devices

2

No

US Distribution to states of: AL, CO, DE, FL, GA, HI, KY, IL, IN, MA, MD, MI, MN, MO, NC,, ND, NJ, NY.OH, PA, and WV.

Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. || The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device will display physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generate an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmias are detected.

Lot/Unit Codes: G9 Serial Number: 230 (UDI: 01049319211121682100230) Serial Number: 232 (UDI: 01049319211121682100232)  Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06, 02-10, or 02-40 software.  Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower.

Cardiovascular Devices

2

No

Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand

Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).

Serial Numbers: MS-110B: (17 units) 00013-00019, 00023- 00032 MS-120BK: (6 units) 0009- 00014 JB-116B: (31 units), 0008, 00012, 00014, 00016, 00018, 00019, 00020, 00021, 00023, 00025, 00026, 00027, 00028, 00029, 00031, 00032, 00034, 00035, 00039, 00043, 00102,00103, 00122-00128, 00134, 00135 JB-132B: (83 units) 00009, 00011, 00012, 00014, 00015, 00016, 00018, 00019, 00020, 00021, 00023, 00024, 00025, 00026, 00027, 00036, 00037, 00038, 00041, 00042, 00043, 00044, 00046, 00047, 00049, 00061, 00062, 00066, 00067, 00068, 00069,00071, 00072, 00074, 00075, 00082, 00084, 0085, 00086, 00090, 00095, 00099, 00120, 00121-00129, 00131-00147, 00149-00155, 00157, 00161, 00164-00168

Neurological Devices

2

No

Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.

MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)