Philips SmartPath Device Recall Over Potential Stiffness Errors
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,438 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.