Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TCM4 Base unit Recalled by Radiometer Medical ApS Due to Reports have been received about the transcutaneous monitoring...
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 Medical ApS directly.
Affected Products
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Usage: It is indicated for use on pediatrics and adults.
Quantity: 84 units
Why Was This Recalled?
Reports have been received about the transcutaneous monitoring system display flickering or monitor becoming non responsive and beeping. This may result in delayed patient monitoring as well as potentially compromise the product performance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Radiometer Medical ApS
Radiometer Medical ApS 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