Philips Ingenia 3.0T Device Recall Announced

Source: FDA · United States

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Philips North America is recalling 64 units of Ingenia 3.0T with MR Elastography devices due to potential errors in stiffness value measurements.

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, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Which Products Are Affected

The affected products are Philips Ingenia 3.0T with MR Elastography devices with the following model numbers: 781342, 781377, and 782103. The 510(k) numbers associated are K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, and K251808. A total of 64 units are affected, distributed US Nationwide and in countries including Argentina, Australia, and others. Specific UDIs and serial numbers for each model are provided in the recall details, such as for model 781342: UDI (01)00884838055339 with serial numbers like 71693, 71581, and more.

What You Should Do

Consumers should follow the initial firm notification, which was issued via letter, and contact Philips North America for further instructions regarding the recall.

Why This Matters

This recall affects medical devices used in diagnostics, potentially leading to inaccurate results that could impact patient care; it involves 64 units distributed worldwide, highlighting the need for accurate medical equipment.

Source

From the FDA, recall number Z-1958-2026.

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 64 units of Ingenia 3.0T with MR Elastography devices due to potential errors in stiffness value measurements.
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.