Ivoclar Vivadent Ltd - 3 Shape Trios 6

Recall Summary Ivoclar Vivadent Ltd is recalling 3Shape Trios 6 products distributed to hospitals, pharmacies, and laboratories in New Zealand. The products will be exchanged as part of this recall action. This is classified as a Class I recall, which indicates a serious issue.

Recalling firm
Ivoclar Vivadent Ltd
Product
Ivoclar Vivadent Ltd - 3 Shape Trios 6. [Device]. Model: TRIOS 6 intraoral scanner. Affected: Serial number - 1ld2519l01122b, 1ld2519l01128b, 1ld2522l01099b
Reason
As part of ongoing optimization of TRIOS Dx Plus proximal caries visualization, the manufacturer has determined that some TRIOS 6 scanners may benefit from a hardware upgrade to ensure the best possible TRIOS Dx Plus experience., This is a proactive upgrade initiative and is unrelated to scanning performance outside the use of proximal caries visualization in Dx Plus.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-04-02
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/afaa897f-cc14-4801-ab89-fc687d0c3bff