Philips North America 2026-05-06 Health serious FDA
Health · FDA · Recall #FDA-Z-1966-2026
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number… Recall
Issued May 6, 2026 · Philips North America
In May 2026, Philips North America recalled the Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Philips North America to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Philips North America
- Category
- Health
- Recall date
- May 6, 2026
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecua
- Recall number
- FDA-Z-1966-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Philips North America has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.