Fore-sight Elite Module Tissue Oximeter
- Recalling firm
- Edwards Lifesciences (New Zealand) Limited
- Product
- Fore-Sight Elite Module Tissue Oximeter. [Device]. Model: Catalog No. HEMFSM10. Affected: Serial numbers: 2008042, 2008043, 2008045, 2008046, 2008047, 21120094, 21120098, 21120099, 21120100, 21120692
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-28
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/cd3e56fc-3f8c-4c40-8294-5ceeb6e0dc50