Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29091 |
| Brand Name: | Fore-Sight Elite Module Tissue Oximeter |
| Model: | HEMFSM10, 01-06-3000 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Edwards Lifesciences (New Zealand) Limited 171 Morrin Road St John Auckland 1072 |
| Contact Information: | 021 313 234 |
| Manufacturer: | Edwards Lifesciences LLC |
| Issue: | The manufacturer has identified that the StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module (Model HEMFSM10) or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor (Model 01-06-3000) with the Fore-Sight Elite large sensor (FSESL) in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 10/3/2023 |
