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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00081-1
Product Name/Description Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor

All Serial Numbers

ARTG Number: 140333
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 5/02/2018
Responsible Entity Radiometer Pacific Pty Ltd
Reason/Issue Radiometer previously informed users that they had received reports of occurrences of the TCM5 causing interferences on ECG and EEG monitors (TGA Ref: RC-2017-RN-01327-1).
There is a possibility that TCM5 FLEX/BASIC can cause interferences to ECG or EEG measurements, however, only when applied on the same patient.
The problem may also concern other highly sensitive devices including: ECG, EEG, EMG, MMG, EOG, GSR, MEG, ICG.

For this reason the Instructions for Use include the following warning:

WARNING – Risk of interference
Other instruments sensitive to electromagnetic interference may be affected by the TC measurement. If this is the case, contact authorised service personnel.

The described effect may potentially lead to incorrect measurement results by 3rd party devices, such as an ECG monitor due to interference by the
TCM5 FLEX / BASIC monitor. These incorrect measurement results may potentially lead to incorrect treatment or management of the patient.
Recall Action Product Defect Correction
Recall Action Instructions Radiometer is advising users to choose one of the options below in order to avoid the issue from occurring.

Option 1: Connect the TCM5 monitoring system to a grounded Ethernet network using a shielded Ethernet cable. Please contact Radiometer if this option is selected. Radiometer will assist in verifying that the Ethernet network is indeed grounded and in selecting types of Ethernet cables verified by Radiometer.

Option 2: Disconnect the TCM5 monitoring from the mains supply and run it on battery only. Users can use the monitor for up to 4 hours with a fully charged battery.

Option 3: If alternative monitoring system is available consider to use that while waiting for the final solution from Radiometer.

In case none of the above options are feasible Radiometer requests users to refrain from combining the TCM5 FLEX/BASIC measurement with an EEG or ECG measurement.

This action has been closed out on 25/03/2019
Contact Information 1800 247 254 - Radiometer