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Terminated

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.

FDA Recall Z-1543-2015 · Posted 2015-04-29

Recall StatusTerminated
Product CodeMHX
Date Initiated2015-04-14
Date Terminated2015-10-01
Product Quantity208 units

Reason for Recall

Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.

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 [email protected]. 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).

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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