Trios 6 System (l1p-2)

TRIOS 6 System Recall Summary The TRIOS 6 System (L1P-2) is being recalled by 3Shape Trios A/S due to a required software upgrade. This is a Class I recall affecting units distributed to hospitals, pharmacies, and laboratories in New Zealand. The recall requires affected devices to receive a software update to address the identified issue.

Recalling firm

Osstem New Zealand Limited

Product

TRIOS 6 System (L1P-2). [Device]. Model: TRIOS 6 intraoral scanner. Affected: 1ld2522l01055b, 1ld2535l01022b

Reason

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...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-03-30

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/40808c73-cc87-4411-9e63-319d506205fc