fda_recall · device_recall · high
Philips North America — Class II recall: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model…
- Event date
- 2026-05-06 00:00:00Z
- Observed
- 2026-07-09 22:52:44Z
- Source ID
- Z-1968-2026
- Payload hash
- 8b5e5e61ff293d7b00a290c6…
Summary
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.