[mdr] Mr Systems On R11, R12.1.1, And R12.2.0

Recalling firm

Philips New Zealand Commercial Limited

Product

[MDR] MR Systems on R11, R12.1.1, and R12.2.0. [Device]. Model: Models: MR7700, Ingenia 1.5T, Ingenia 3.0T, Ingenia Elition S 3.0T, Ingenia Elition X 3.0T, Ingenia Ambition 1.5T S, Ingenia Elition S. Affected: Model number: 782153, 781341, 781342, 781357, 781358, 781359, 782106

Reason

The manufacturer has identified software problems affecting MR systems on software versions R11, R12.1.1 and R12.2.0. The problems have no associated safety impact and do not prevent the system from functioning in accordance with the intended use; however, they can cause inconvenience for operators.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-10-05

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/407fe9de-c828-47ef-853f-e5203eb9c748