Philips North America 2026-02-04 Health serious FDA
Health · FDA · Recall #FDA-Z-1215-2026
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version… Recall
Issued February 4, 2026 · Philips North America
In February 2026, Philips North America recalled the SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version…, 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 viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
What you should do
- 1 Stop using SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version… 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
- February 4, 2026
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, IL, MA, ME, MI, MN, MS, NE, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and t
- Recall number
- FDA-Z-1215-2026
- 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.