Radiometer TCM4 Base Units Recalled for Electrical Safety Non-Compliance
Radiometer America Inc is recalling TCM4 series Base Units and Power Supplies because they do not comply with IEC 60601-1 Sub Clause 15B electrical safety standards.
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, but the source text does not report any hospitalizations, injuries, or deaths. It is a compliance issue regarding electrical safety standards without reported harm, fitting the Moderate category for low-risk or precautionary recalls.
Plain-English summary
Radiometer America Inc is recalling TCM4 series Base Units and spare part Power Supplies. The recall was initiated because the devices do not comply with IEC 60601-1 Sub Clause 15B, a standard related to electrical safety in medical equipment.
The affected products are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate. A total of 5,874 units are involved in this recall. The devices were distributed nationwide in the United States and in Canada.
No specific injuries or illnesses have been reported in the source text. Consumers and healthcare facilities should check their device serial numbers against the list provided in the official recall notice to determine if their equipment is affected.
The recalled product
- Product
- TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
- Manufacturer
- Radiometer America Inc
- Hazard
- Affected units
- 5,874
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 (20)
- TCM4 series Base Units: 000-154
- 391-876
- 154R0004N003
- 154R0004N008
- 154R0005N004
- 154R0005N005
- 154R0005N005-U
- 154R0005N006-154R0005N006
- 154R0006N005
- 154R0006N006
- 154R0006N008-154R0006N010
- 154R0007N001-154R0007N010
- 154R0008N001
- 154R0008N002
- 154R0008N002U
- 154R0008N003
- 154R0008N005-154R0008N010
- 154R0009N004
- 154R0009N010
- 154R0011N003
Distribution
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