Reported Apr 29, 2020 · Terminated
TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778,…
Radiometer Medical ApS
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 Medical ApS · Akandevej 21 · Bronshoj, N/A · N/A
Is this the product you have?
TCM4 Base unitRef 391-880
- UDI
(01)05700693918808used with the monitor modules TCM4 (902-778)TCM40 (902-778902-946 or 902-862)TCM400 (902-564)TOSCA (903-044)
- and CombiM (903-111) - Product UsageIt is indicated for use on pediatrics and adults
- Lot codes and dates
- Affected Serial Numbers
391-880R0471N017391-880R0471N030391-880R0473N006391-880R0473N016391-880R0471N021391-880R0472N010391-880R0473N007391-880R0471N022391-880R0472N011391-880R0473N008391-880R0471N023391-880R0472N014391-880R0473N009391-880R0471N024391-880R0472N016391-880R0473N010391-880R0471N025391-880R0472N020391-880R0473N011391-880R0471N026391-880R0473N001391-880R0473N020391-880R0471N027391-880R0473N002391-880R0473N013391-880R0471N028391-880R0473N003391-880R0473N014391-880R0471N029391-880R0473N005391-880R0473N015
- Affected Serial Numbers
- Amount recalled
- 84 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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