# FDA recall Z-1162-2021

> **Nihon Kohden America Inc** · Class II · device recall initiated 2021-01-08.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1162-2021
- **Recalling firm:** Nihon Kohden America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-08
- **Report date:** 2021-03-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Foothill Ranch, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1162-2021

## Citation

> AI Analytics. FDA recall Z-1162-2021. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-1162-2021. Source: US FDA. Licensed CC0.

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