Remote Network Station — Class II medical device recall Z-1543-2015
Terminated recall by Nihon Kohden America Inc, reported 2015-05-06, distributed in AL, CO, DE, FL, GA, HI, IL, IN…. Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
| Recall number | Z-1543-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nihon Kohden America Inc, Irvine, CA, United States |
| Recall initiated | 2015-04-14 |
| Classified | 2015-04-28 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-10-01 |
| Distributed | AL, CO, DE, FL, GA, HI, IL, IN, KY, MA, MD, MI, MN, MO, NC, ND, NJ, NY, OH, PA, WV |
| Quantity | 208 units |
| Reason classes | device malfunction |
| Serial numbers | 2002, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011, 2012, 2013, 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021, 2022, 2023, 2024, 2025, 2026 and 86 more |
| Model numbers | RNS-9703, RNS-9703-19, RNS-9703-24 |
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.
Reason for recall
Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1543-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.