Z-1162-2021 Class II Ongoing

Recalled by Nihon Kohden America Inc — Foothill Ranch, CA

Recall Details

Product Type
Devices
Report Date
March 10, 2021
Initiation Date
January 8, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4,436

Product Description

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 Pattern

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.

Code Information

ORG 9100A serial numbers: 00001 to 01413 ORG 9110A serial numbers: 00001 to 02706 ORG 9700A serial numbers: 00001 to 00894