Recall Z-1162-2021— Nihon Kohden America Inc

Name: FDA recall Z-1162-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-08

Class II · Ongoing

Class II FDA medical device recall by Nihon Kohden America Inc, initiated 2021-01-08. It names one FDA 510(k) clearance: K071058. 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..

Recalling firm: Nihon Kohden America Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-01-08
Firm location: Foothill Ranch, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K071058 — MULTIPLE PATIENT RECEIVER, MODEL ORG-9700ANihon Kohden America, Inc.·cleared 2007-06-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.