Recall of Philips SmartPath to Ingenia Elition X Devices
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Philips North America is recalling three units of specific models of the SmartPath to Ingenia Elition X with MR Elastography devices due to potential errors in stiffness value reconstruction.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 13, 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, which could lead to incorrect reconstruction voxel size settings in the default MRE scan protocol.
Which Products Are Affected
The affected products are Philips SmartPath to Ingenia Elition X with MR Elastography (MRE) devices. The specific models are: 1. Model Number (REF): 782118 with UDI: (01)00884838099746(21)85655 and Serial Number: 85655; 2. Model Number (REF): 782144 with UDI: (01)00884838108677(21)71087 and Serial Number: 71087; 3. Model Number (REF): 782163 with UDI: (01)00884838115743(21)42299 and Serial Number: 42299. A total of 3 units are affected. The distribution is worldwide, including US nationwide and various countries such as Argentina, Australia, and others.
What You Should Do
Consumers who have these devices should contact Philips North America as per the initial firm notification letter for further instructions on the recall.
Why This Matters
This recall addresses potential inaccuracies in medical imaging devices, which could affect diagnostic results, highlighting the importance of precise equipment in healthcare to ensure patient safety.
Source
FDA recall notice Z-1968-2026. For more information, visit the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,409 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.