Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37388 |
| Brand Name: | Fore-Sight Elite Module Tissue Oximeter |
| Model: | Catalog No. HEMFSM10 |
| Affected: | Serial numbers: 2008042, 2008043, 2008045, 2008046, 2008047, 21120094, 21120098, 21120099, 21120100, 21120692 |
| 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, during manufacturing, the laterality identification labels may have been omitted or incorrectly applied to the device. Specifically, there is a possibility that the labels on the green cables were switched, resulting in the channel 1 cable being labelled as channel 2 and the channel 2 cable being labelled as channel 1. This may cause a discrepancy between the left and right values displayed on the monitor and the corresponding labels on the cables. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 28/8/2026 |
