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Medium risk Drugs & MedicationsClass II

Philips North America Recall

Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

Updated December 3, 2025

Philips North America is recalling Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.. Hazard: The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Is the Philips North America recalled? Yes. This product was recalled by FDA on December 3, 2025. Details below.

What is recalled

Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Brands affected

Philips North America
Source
FDA
Category
Drugs & Medications
Recall ID
fda-Z-1208-2026
Classification
Class II
Recalled
December 3, 2025
Read the official notice

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