Urgent Field Safety Notice For Achieva 3.0t/xr, Evolution Upgrade 1.5t/3.0t, Ingenia 1.5t/1.5t S/3.0t/3.0t Cx/ambition S/ambition X/elition S/elition X/intera 3.0t Quasar Dual, Mr 5300, Mr 7700, Smart

Recall Summary Philips is issuing an urgent safety notice for multiple MRI scanner models (including Achieva, Evolution, Ingenia, Ambition, Elition, Intera, MR 5300, MR 7700, and Smart systems) distributed in Germany and the EU. The notice is classified as Class I, indicating a serious issue, though the specific hazard is not detailed in the provided information. This affects healthcare facilities and imaging centers that operate these MRI devices.

Recalling firm

Urgent Field Safety Notice for Achieva 3.0T/XR, Evolution upgrade 1.5T/3.0T, Ingenia 1.5T/1.5T S/3.0T/3.0T CX/Ambition S

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Achieva 3

Reason

assessment Field corrective actions Urgent Field Safety Notice for Achieva 3

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-05-22

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/283d2a99-5624-4e77-8e69-ee8cd3c94151