Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TCM4 series Base Units Recalled by Radiometer America Inc Due to RADIOMETER became aware that the TCM4 series Base...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Radiometer America Inc directly.
Affected Products
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.
Quantity: 5,874 units
Why Was This Recalled?
RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Radiometer America Inc
Radiometer America Inc has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report