Philips SmartPath Device Recall for Stiffness Value Errors

Source: FDA · United States

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

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What Happened

Philips North America is recalling certain medical devices due to 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.

Which Products Are Affected

The affected products are Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). The specific model numbers are 781260 and 782112. For model 781260, the UDI is (01)00884838095076(21)21554, (01)00884838095076(21)13018, (01)00884838095076(21)12033, with serial numbers 21554, 13018, and 12033. For model 782112, the UDI is (01)00884838098886(21)30143, (01)00884838098886(21)22051, (01)00884838098886(21)32156, with serial numbers 30143, 22051, and 32156. A total of 6 units are affected, distributed US Nationwide and in countries including Argentina, Australia, and others.

What You Should Do

Consumers who have these devices should follow the instructions in the letter from Philips North America, as the recall was initiated via letter.

Why This Matters

This recall involves medical devices that could lead to inaccurate imaging results, potentially affecting patient care in healthcare settings.

Source

This information is from the FDA recall notice, recall number Z-1965-2026.

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 voluntarily recalling six units of its SmartPath to dStream devices due to potential errors in stiffness values during medical 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.