Reported Mar 10, 2021 · Ongoing

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/…

Nihon Kohden America Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nihon Kohden America Inc · 90 Icon · Foothill Ranch, CA · 92610-3000

Is this the product you have?

  • WMTS Telemetry Receiver, Multiple Patient Receiver
  • Model Number/ UDIORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Lot codes and dates
  • ORG 9100A serial numbers00001
  • to 01413 ORG 9110A serial numbers00001
  • to 02706 ORG 9700A serial numbers00001 to 00894
Amount recalled
4,436

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.