Nihon Kohden Remote Network Station Recall for Alarm Failure
Nihon Kohden America is recalling 208 Remote Network Station units because they may fail to sound alarms for critical patient conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may fail to sound alarms for life-threatening conditions, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Nihon Kohden America Inc. is recalling 208 units of the Remote Network Station (RNS) 9703, specifically models RNS-9703-19 and RNS-9703-24 with software version 02.40. The device is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. It displays physiological data from up to 16 telemetry receiver/transmitters or bedside monitors and generates alarms when measured parameters fall outside pre-set limits or when life-threatening arrhythmias are detected.
The recall is being issued because the device may fail to sound. This defect poses a risk to patient safety as medical professionals may not be alerted to critical changes in a patient's condition. The affected units were distributed in the United States to the states of AL, CO, DE, FL, GA, HI, KY, IL, IN, MA, MD, MI, MN, MO, NC, ND, NJ, NY, OH, PA, and WV.
Medical facilities should identify affected units by checking the model number and serial number against the provided list. Affected serial numbers include 2002 and higher for both model variants, with specific units listed in the recall documentation. Facilities should contact Nihon Kohden America for instructions on how to address the defect.
The recalled product
- 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 w
- Manufacturer
- Nihon Kohden America Inc
- Affected units
- 208
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