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Health product recall

TCM COMBI M MODULES (2015-11-16)

Starting date:
November 16, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-56288

Affected Products

TCM COMBI M MODULES (2015-11-16)

Reason

After running without any problems and with the volume control set to 1 the analyzer gave an alarm which was significantly louder than the specified highest possible level.

Affected products

TCM COMBI M MODULES (2015-11-16)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

903-111

Companies
Manufacturer
Radiometer Medical Aps
Akandevej 21
Bronshoj
2700
DENMARK