Nihon Kohden America Inc Recall 87264
Description: WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Nihon Kohden America Inc Recall 87264 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1162-2021 |
| Event ID | 87264 |
| Event Description | WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI |
| Product Type | Devices |
| 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. |
| Quantity | 4,436 |
| Recall Reason | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. |
| Device Classification | 20210310 |
| Device Code Info | ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894 |
| Center Classification Date | 20210302 |
| Recall Initiation Date | 20210108 |
| Recalling Firm | Nihon Kohden America Inc |
| Initial Notification | Letter |
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