Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 25945 |
| Brand Name: | Patient monitor module, multifunction |
| Model: | |
| Affected: | - ECG malfunction |
| Software version: | |
| Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
| Contact Information: | 0800 659 465 |
| Manufacturer: | GE Medical Systems Information Technologies Inc |
| Issue: | The CARESCAPE ONE monitor may lose ECG parameter and waveform data when used in conjunction with an Automated External Defibrillator (AED) or any AED capable defibrillator when used in AED mode. If this situation occurs, the CARESCAPE ONE will display "ECG Malfunction" and "Check Device" technical alarms. This issue can result in delayed clinical assessment of a life-threatening ECG arrhythmia event. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/4/2020 |
