Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 27847 |
| Brand Name: | Patient monitor module, multifunction |
| Model: | CARESCAPE PDM (New) - 2042084-001, CARESCAPE PDM (Goldseal) - 2094504-001 |
| Affected: | |
| 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 manufacturer has identified that if the CARESCAPE PDM with Masimo SET technology has not been powered down completely in more than 2 years, it can display a frozen SpO2 saturation value that is inaccurate and no longer changes to reflect the patient's clinical condition. If this situation were to occur, it could result in missed SpO2 alarms and delayed diagnosis and treatment of hypoxia or hyperoxia. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/6/2021 |
