Nihon Kohden America Inc: Medical Device Recall in 2021 - (Recall #: Z-1162-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI

Product Classification:

Class II

Date Initiated: January 8, 2021

Date Posted: March 10, 2021

Recall Number: Z-1162-2021

Event ID: 87264

Reason for Recall:

Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

Status: Ongoing

Product Quantity: 4,436

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated