Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36692 |
| Brand Name: | TRIOS 6 System (L1P-2) |
| Model: | TRIOS 6 intraoral scanner |
| Affected: | 1ld2522l01055b, 1ld2535l01022b |
| Software version: | |
| Recalling Organisation: | Osstem New Zealand Limited 10/6 Omega Street Rosedale Auckland 0632 |
| Contact Information: | |
| Manufacturer: | 3Shape Trios A/S |
| Issue: | The manufacturer has identified that a reflective surface inside the TRIOS 6 scanner front tube (frame 10032019) can lead to infrared (IR) straylight, which may produce image artefacts when using the SaMD TRIOS Dx Plus (proximal caries visualisation). Artefacts may appear across multiple teeth in severe cases, or as localised glare in moderate cases. Localised glare may increase the likelihood of false positives for proximal caries, however, the risk of this problem leading to patient harm is low/negligible, as TRIOS Dx Plus is to be used only as an adjunct/aid. Direct visual and tactile examination performed during the checkup would likely confirm the false positive. If uncertainty remained after the clinician's examination, a confirmatory X-ray would be taken |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/3/2026 |
