Reported Aug 14, 2013 · Terminated
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark,…
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 · 810 Sharon Dr · Westlake, OH · 44145-1521
Is this the product you have?
- 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.
- Lot codes and dates
- TCM4 series Base Units
000-154391-876391-878 and 391-880 below
- R0175N009 & Power Supply (Spare part)
870 of 870 codes
910-246. Serial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
- TCM4 series Base Units
- Amount recalled
- 5,874 units
Where it was sold
Why it was recalled
RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
This product could cause temporary or reversible health problems — stop using it.
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