Drug recall
WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/…
FDA recall event 87264 · Class II · Nihon Kohden America Inc
Key facts
| Event ID | 87264 |
|---|---|
| Recall numbers | Z-1162-2021 |
| Recalling firm | Nihon Kohden America Inc |
| Product type | Devices |
| Products | WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. |
| Initiation date | Jan 8, 2021 |
| Report date | Mar 10, 2021 |
| City | Foothill Ranch |
| State | CA |
| Country | United States |
| FEI number | 2080783 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: