Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22759 |
| Brand Name: | Radiometer Transcutaneous blood gas monitor |
| Model: | All when used with ECG or EEG monitoring |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Radiometer Pacific Suite 1 1/30 Benedicts Street Eden Terrace Auckland 1010 |
| Contact Information: | 0800 723 722 |
| Manufacturer: | Radiometer Basel AG |
| Issue: | The manufacturer 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. Update: The manufacturer has now announced the release of the final permanent countermeasure solution and will implement the exchange of the existing customer TCM5FLEX/Basic with a redesigned TCM5 monitoring system. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/3/2019 |
