WMTS Telemetry Receiver — Class II medical device recall Z-1162-2021
Ongoing recall by Nihon Kohden America Inc, reported 2021-03-10, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
| Recall number | Z-1162-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nihon Kohden America Inc, Foothill Ranch, CA, United States |
| Recall initiated | 2021-01-08 |
| Classified | 2021-03-02 |
| Reported by FDA | 2021-03-10 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Quantity | 4,436 |
| UPC / GTIN / UDI-DI | 00841983102554, 00841983102561 |
| Serial numbers | 00001, 00894, 01413ORG, 02706ORG, 9110A, 9700A |
Product
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Reason for recall
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
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-1162-2021. 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.