Food, drugs, devices › Nihon Kohden America Inc
Device recall: Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is in
FDA enforcement event 71015 is a device recall by Nihon Kohden America Inc of Irvine, CA, initiated 14 Apr 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 1 Oct 2015. Initiation: voluntary: firm initiated. Nihon Kohden America Inc has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Nihon Kohden America Inc, Irvine, CA.
Reason for recall
"Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound."
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1543-2015 | 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… | 208 units | Class II | Terminated | 6 May 2015 |
Context
Other enforcement events for Nihon Kohden America Inc
All 9 events for Nihon Kohden America Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Oct 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.