Philips Evolution Upgrade 3.0T Recall for Stiffness Value Errors
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Philips North America is voluntarily recalling three units of their Evolution upgrade 3.0T devices due to potential errors in stiffness values from specific image reconstruction parameters.
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, fda, 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 Products Are Affected
The affected products are the Philips Evolution upgrade 3.0T with MR Elastography (MRE). The specific models are: 1. Model Number (REF): 782143, with UDI: (01)00884838108660(21)42218 and (01)00884838108660(21)42225, and Serial Numbers: 42218, 42225. 2. Model Number (REF): 782162, with UDI: (01)00884838115736(21)71403, and Serial Number: 71403. A total of 3 units are affected, distributed worldwide, including US Nationwide and various countries such as Argentina, Australia, and others.
What You Should Do
Consumers who have the affected devices should follow the initial firm notification, which was issued via letter, and contact Philips North America for further instructions on the voluntary recall.
Why This Matters
This recall involves medical devices that could lead to inaccurate results, potentially affecting diagnostic accuracy in a limited number of cases.
Source
FDA recall notice Z-1955-2026
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 (1,185 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.