Philips SmartPath Device Recall for Stiffness Value 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 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 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 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 ↗
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 (1,372 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.