Class 2 Device Recall Remote Network Station 9703

• Date Initiated by Firm: April 14, 2015
• Date Posted: April 29, 2015
• Recall Status: Terminated on October 01, 2015
• Recall Number: Z-1543-2015
• Recall Event ID: 71015
• 510(K)Number: K023475
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Nihon Kohden America Inc; 15353 Barranca Pkwy; Irvine CA 92618-2216
• For Additional Information Contact: 949-580-1555
• Manufacturer Reason for Recall: Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Nihon Kohden, sent an Urgent Medical Device Alert" letter dated 4/14 /15 to customers. The letter describes the product, problem and actions to be taken. The customers were instructed to stop using the RNS for primary alarm notification and instead utilize the CNS and or the Bedside monitor for primary alarm notification, until such time NKA can provide corrective measures to your facility; Inform potential users in your organization of this notification, and complete the attached reply form and return it by fax (949) 580-1550 or email it to RNS_Replay@nkusa.com. Customers with questions are instructed to contact NKA Technical Support Center at (800) 325-0283 Ext 6 (available 24 hours a day/7 days/week).
• Quantity in Commerce: 208 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MHX and Original Applicant = NIHON KOHDEN AMERICA, INC.