Recall of Philips Ingenia 1.5T CX Medical Device

Source: FDA · United States

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 recalling one unit of the Ingenia 1.5T CX with MR Elastography due to potential errors in stiffness value measurements from specific image reconstruction parameters.

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.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

Recall Article

What Happened

Philips North America is initiating a recall for the Ingenia 1.5T CX with MR Elastography 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 incorrect reconstruction voxel size settings in the default MRE scan protocol.

Which Products Are Affected

The affected product is the Philips Ingenia 1.5T CX with MR Elastography, Model Number: 781262. Only 1 unit is involved, with Serial Number: 77144 and UDI: (01)00884838068445(21)77144. This recall applies to products distributed worldwide, including the United States and other countries such as Argentina and Australia.

What You Should Do

Consumers with the affected unit should contact the recalling firm, Philips North America, as per the initial notification letter for instructions on handling the product.

Why This Matters

This recall is significant because it could result in inaccurate medical imaging results, potentially affecting diagnostic accuracy, though the risk of serious health consequences is considered remote.

Source

This information is attributed to the FDA. For details, refer to the FDA recall page for recall number Z-1957-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Philips North America is recalling one unit of the Ingenia 1.5T CX with MR Elastography due to potential errors in stiffness value measurements from specific image reconstruction parameters.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.