| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00299-1 |
| Product Name/Description |
Radiometer TCM5 FLEX/ BASIC Transcutaneous Monitor
All Serial Numbers
ARTG Number: 140333
(Radiometer Pacific - Transcutaneous blood gas monitor) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Radiometer previously informed users that they had received reports that instruments sensitive to electromagnetic interference may be affected by TCM5 measurements (TGA Ref: RC-2018-RN-00081-1 and RC-2017-RN-01327-1).
Radiometer has released the revised version of the instructions for use which includes a separate paragraph in the Introduction section under “Electromagnetic interference”. This amendment is included from the TCM5 Instructions for Use, 996-436, version 201801F, pages 5 and 6. The updated IFU mirror the actions for users identified in RC-2018-RN-00081-1. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Radiometer is advising users to discard previous revisions of the Instructions for Use and replace these with the new versions.
Radiometer is working on a solution, which involves a hardware redesign of the TCM5 monitoring system, for this issue. Users will be contacted by their Radiometer representative when the final solution is available.
This action has been superseeded by RC-2019-RN-00374-1 |
| Contact Information |
1800 247 254 - Radiometer Pacific |