Recall of Philips Evolution Upgrade 1.5T Devices
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Philips North America is recalling specific models of the Evolution Upgrade 1.5T with MR Elastography due to potential errors in stiffness value measurements affecting image reconstruction.
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 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 the Philips Evolution Upgrade 1.5T with MR Elastography 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 the Philips Evolution Upgrade 1.5T with MR Elastography, specifically:
- Model Number: 782116, with UDIs: (01)00884838099722(21)41527, (01)00884838099722(21)70949, (01)00884838099722(21)84741, and Serial Numbers: 41527, 70949, 84741.
- Model Number: 782148, with UDIs: (01)00884838108714(21)84560, (01)00884838108714(21)41277, (01)00884838108714(21)70769, (01)00884838108714(21)70983, and Serial Numbers: 84560, 41277, 70769, 70983.
- Model Number: 782166, with UDI: (01)00884838115774(21)70042, and Serial Number: 70042. A total of 8 units are affected, and these products were distributed worldwide, including nationwide in the US and countries such as Argentina, Australia, and others.
What You Should Do
Consumers who have the affected devices should contact Philips North America as per the initial firm notification, which was issued via letter, for instructions on the recall process, including potential returns or corrections.
Why This Matters
This recall highlights potential risks in medical device accuracy that could impact diagnostic procedures, emphasizing the need for reliable imaging technology in healthcare.
Source
This information is from the FDA recall notice Z-1954-2026.
Original source: FDA Official Notice ↗
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