Philips North America is recalling 121 various Magnetic Resonance (MR) imaging systems due to a software defect that can cause incorrect stiffness values to be displayed on MR Elastography (MRE) stiffness maps. This issue occurs when the maps are exported to a Picture Archiving and Communication System (PACS) for viewing by clinicians. The recall affects several models including Ingenia, MR 7700, and Evolution Upgrades equipped with software versions R11.1 and R12.1. Philips is initiating this voluntary recall to correct the software error and ensure diagnostic accuracy.
If a clinician relies on an incorrect stiffness map, they may misinterpret the mechanical properties of a patient's tissue (such as liver stiffness). This could lead to an incorrect diagnosis or the selection of an inappropriate treatment plan for the patient.
Recall #: Z-1204-2026
Recall #: Z-1205-2026
Recall #: Z-1206-2026
Recall #: Z-1207-2026
Recall #: Z-1208-2026
Recall #: Z-1209-2026
Recall #: Z-1210-2026
Recall #: Z-1211-2026
Recall #: Z-1212-2026
Recall #: Z-1213-2026
Recall #: Z-1214-2026
Recall #: Z-1215-2026
Recall #: Z-1216-2026
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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