| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01327-1 |
| Product Name/Description |
Radiometer TCM5 FLEX / BASIC Transcutaneous Monitor
(when used with ECG or EEG monitoring)
All Serial Numbers
ARTG Number: 140333 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer has recently received reports of occurrences of the TCM5 causing interferences on ECG and EEG monitors. There is a possibility that
TCM5 FLEX / BASIC can cause interferences to ECG or EEG measurements, however, only when applied on the same patient.
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 |
Recall for Product Correction |
| Recall Action Instructions |
Radiometer is advising users who perform ECG measurements in combination with the TCM5 FLEX/ BASIC on a patient to implement one of the counter measures below to reduce/prevent the interference.
1. Disconnect the TCM5 FLEX/BASIC from the mains supply and run it on battery only. This will prevent the interference from occurring on an ECG or EEG monitor.
2. Do not use both the TCM5 FLEX/BASIC and an ECG or EEG monitor simultaneously on the same patient.
Radiometer is revising the Instructions for Use and will provide these to customers when available. Radiometer will contact affected customers when a solution becomes available.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 247 254 - Radiometer Pacific |