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
Recall Summary Philips Medical Systems is recalling multiple MRI machine models (Evolution Upgrade, Ingenia, Ambition, Elition, MR 5300, MR 7700, and SmartPath to dStream systems) distributed in Germany and the EU due to an unspecified safety issue. This is classified as a Class I recall, indicating a serious problem. The affected machines are used in medical facilities for diagnostic imaging.
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Product
- 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
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-07-01
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/6555e43c-624a-4378-8f2e-af083ec16fa4