Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.
FDA device recall Z-1966-2026 · posted 2026-04-27 · Open, Classified
Recall details
- Recalling firm
- Philips North America
- Reason for recall
- 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.
- Action taken
- Philips Medical notified consignees on about 04/14/2026 via letter. Consignees were made aware of the issue, affected units, and instructed to continue to use MDE as per established guidelines, manually update the scan protocol settings according to the directions provided to prevent the issue from occurring, and continue using the systems in accordance with their intended use. Consignees were also instructed to circulate the notice to all users for awareness, retain the Urgent Medical Device letter with affected systems until the software upgrade is installed and complete and return the provided response form.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LNH
- Quantity affected
- 1 unit
- Distribution
- Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indon
- Date initiated
- 2026-04-14
- Date posted
- 2026-04-27
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems (K213583) | Philips Medical Systems Nederland B.V. | 2022-05-16 |