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 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.
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 ↗
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