Philips SmartPath Device Recall Over Potential Stiffness Errors

Source: FDA · United States

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Philips North America is recalling 14 units of its SmartPath to dStream medical devices due to potential errors in stiffness values during imaging.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on May 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What Happened

Philips North America has initiated a recall because of the potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to incorrect reconstruction voxel size settings in the default MRE scan protocol.

Which Products Are Affected

The affected products are Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE), with the following model numbers: 781270 and 782113. A total of 14 units are involved. For model 781270, the UDIs include (01)00884838095083 with various serial numbers: 38109, 17386, 38356, 34211, 38113, 17356, 38111, 74011, 24058, 24066, and 34223. For model 782113, the UDIs include (01)00884838098909 with serial numbers: 38066, 38117, and 17384. These products were distributed worldwide, including US Nationwide and countries such as Argentina, Australia, and others.

What You Should Do

Consumers and users should contact the recalling firm, Philips North America, as the initial notification was made via letter, for instructions on how to proceed with the recall.

Why This Matters

This recall affects 14 medical devices that could produce inaccurate imaging results, potentially impacting diagnostic accuracy in healthcare settings across the United States and internationally.

Source

Attribution: FDA, recall number Z-1967-2026. For more information, visit the FDA website.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Philips North America is recalling 14 units of its SmartPath to dStream medical devices due to potential errors in stiffness values during imaging.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.