Recall Z-1543-2015 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Nihon Kohden America Inc
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 whe
| Date | Apr 29, 2015 (initiated Apr 14, 2015) |
| Status | Terminated |
| Reason | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound. |
| Root 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 q |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023475 | CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES Nihon Kohden America, Inc., Oct 24, 2002 |