International safety notice

Urgent Field Safety Notice for Evolution Upgrade 1.5T, 3.0T; Ingenia 1.5T, 1.5T CX, 1.5T S. 3.0T, 3.0T CX, Ambition S. Ambition X, Elition S. Elition X; MR 5300, MR 7700; SmartPath to dStream for 1.5T, 3.0T, XR and 3.0T, Ingenia Elition X; Upgrade to MR 7700 by Philips Medical Systems Nederland B.V.

Germany / BfArM · DEU · Sep 10, 2025

Key facts

Title Urgent Field Safety Notice for Evolution Upgrade 1.5T, 3.0T; Ingenia 1.5T, 1.5T CX, 1.5T S. 3.0T, 3.0T CX, Ambition S. Ambition X, Elition S. Elition X; MR 5300, MR 7700; SmartPath to dStream for 1.5T, 3.0T, XR and 3.0T, Ingenia Elition X; Upgrade to MR 7700 by Philips Medical Systems Nederland B.V.
Regulator Germany / BfArM
Country DEU
Brand 1.5T, 3.0T, XR and 3.0T, Ingenia Elition X; Upgrade to MR 7700
Manufacturer Philips Medical Systems Nederland B.V.
Models 781342, 782109, FCO78100584, 782103, 782130, 781359, 781271, 781377, R12.1, 782117, 782138, 782143 and 38 more
Date Sep 10, 2025
Regulator page bfarm.de

At a glance

  • No Recall
  • No Field safety notice

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices