CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report

SmartPath to dStream for XR and 3.0T recalled by Philips North America

Philips North America is recalling SmartPath to dStream for XR and 3.0T, distributed nationwide in the US. The recall was initiated on 3 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMR systems with SW version R11.1 and R12.1. Product Code (REF): 781270. UDI-DI: 00884838095083. Serial Numbers: 24066, 38113, 17356.

Quantity recalled3 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1216-2026
FDA event ID: 98111
Recalling firm: Philips North America, Cambridge, MA
Classification: Class II
Status: Ongoing
Recall initiated: 3 Dec 2025
FDA classified: 29 Jan 2026
Reported: 4 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Dec 2025	Recall initiated by company
29 Jan 2026	Classified by FDA	+57 days
4 Feb 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Product as listed by the FDA

SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

Where it was distributed

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 the countries of Belgium, Canada, Denmark, France, Germany, Greece, India, Israel, Japan, Kenya, Netherlands, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom.

Nationwide Arizona California Colorado Illinois Massachusetts Maine Michigan Minnesota Mississippi Nebraska New York Ohio Oregon Pennsylvania South Carolina Tennessee Texas Virginia Vermont Washington

Questions about this recall

Why was it recalled?

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Which lots are affected?

MR systems with SW version R11.1 and R12.1. Product Code (REF): 781270. UDI-DI: 00884838095083. Serial Numbers: 24066, 38113, 17356.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

12 other products · FDA event 98111

This product is part of a recall event; the main page for the event is SmartPath to dStream for 3.0T recalled by Philips North America.

Reported	Class	Recall	Company	Reason	Where
4 Feb 2026	CLASS II	SmartPath to dStream for 3.0T recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Ingenia Ambition recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Evolution Upgrade 1.5T recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Ingenia 3.0T recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems recalled	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Ingenia 3.0T CX recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Ingenia Elition recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Evolution Upgrade 3.0T recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Ingenia Ambition recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Ingenia Elition recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Other	Nationwide
4 Feb 2026	CLASS II	Ingenia 1.5T recalled by Philips North America	Philips North America	Other	Nationwide

More recalls from Philips North America

All 558

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	SmartPath to dStream for XR and 3.0T recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Upgrade to MR recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Elition S and Ingenia Elition recalled by Philips North America	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Ambition S and Ingenia Ambition recalled	Philips North America	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Ingenia Blue Seal SE and Blue Seal XE recalled by Philips North America	Philips North America	Device Malfunction	Nationwide

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