SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and
Pending LLM rewrite. Source: FDA_DEVICE Z-1215-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
The recalled product
- Product
- SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
- Manufacturer
- Philips North America
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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