The Recall Desk
ModerateFDA (Devices)·Z-1595-2016·Announced 2016-05-11

Radiometer TCM CombiM Modules Recalled for Alarm Volume Error

Radiometer America is recalling TCM CombiM Modules 903-111 because the alarm may sound louder than the pre-set maximum volume.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves an alarm volume error rather than a direct physical injury or life-threatening malfunction, fitting the criteria for a moderate severity recall.

Plain-English summary

Radiometer America, Inc. is recalling TCM CombiM Modules 903-111. The recall involves 1,488 units distributed nationwide in the United States and to numerous countries worldwide.

The recall is being issued because, on rare occasions, the modules may have an error that causes the alarm to sound at a volume higher than the pre-set maximum. The affected units are identified by Part Number 903-111 and Lot Numbers below R0174.

Consumers and healthcare facilities should contact Radiometer America, Inc. for instructions on how to resolve the issue with the affected modules.

The recalled product

Product
TCM CombiM Modules 903-111
Manufacturer
Radiometer America Inc
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
1,488

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part Number: 903-111 Lot Number: Below R0174

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Related recalls

Same manufacturer · Radiometer America Inc

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