Reported May 11, 2016 · Terminated

TCM CombiM Modules 903-111

Radiometer 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: Radiometer America Inc · 250 S Kraemer Blvd · Brea, CA · 92821-6232

Is this the product you have?

  • TCM CombiM Modules 903-111
Lot codes and dates
  • Part Number903-111
  • Lot NumberBelow R0174
Amount recalled
1488

Where it was sold

Why it was recalled

Radiometer America, Inc. is recalling TCM CombiM on rare occasions they may have an error that can cause the alarm to sound higher than the pre-set maximum volume.

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

Notice updated Mar 27, 2018 · Data as of Sep 19, 5:20 PM UTC

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