Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22316 |
| Brand Name: | Transcutaneous blood gas monitor |
| Model: | |
| Affected: | Product code TCM5FLEX/BASIC |
| 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 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. This situation only affects customers who use the TCM5 FLEX/BASIC in combination with an ECG or EEG measurement on a patient. Latest Updated recall action The manufacturer is advising that other instruments sensitive to electromagnetic interference may be affected by the TC measurement. In a worst-case scenario, the described error may result in insufficient or no treatment for a critically low heart rate or critical arrhythmias. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/1/2018 |
