Class II — Nihon Kohden America Inc
| Recalling firm | NIHON KOHDEN CORP. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. |
| Product | WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI |
| Quantity | 4,436 |
| Distribution | US - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, ME, MA, MD, MI, MS, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA WI, WV and WY. |
| Initiated | 2021-01-08 |
| Classified | 2021-03-02 |
| Recall number | Z-1162-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nihon Kohden America Inc (Z-1162-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87264/
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