FDA Device recall Z-1162-2021
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
- FDA Device
- Class II
- ongoing
- Published 2021-03-10
On 2021-03-10 the FDA classified a Class II recall of WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI by Nihon Kohden America, citing incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1162-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-01-08 |
| Published | 2021-03-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Nihon Kohden America |
| Distribution | 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 |
Product
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Reason
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Identifiers
| code_info | ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1162-2021%22
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