Recall of Philips Ingenia Ambition S Devices

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 seven units of Ingenia Ambition S with MR Elastography due to potential stiffness value errors in imaging 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.

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, cpsc, 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 recalling the 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 Ambition S with MR Elastography (MRE). The specific model numbers are: 781359, 782108, and 782139. A total of 7 units are involved. For model 781359, UDIs are (01)00884838090057(21)48218 and (01)00884838090057(21)48233, with serial numbers 48218 and 48233. For model 782108, UDIs are (01)00884838098343(21)48652, (01)00884838098343(21)48551, and (01)00884838098343(21)48669, with serial numbers 48652, 48551, and 48669. For model 782139, UDIs are (01)00884838108639(21)29076 and (01)00884838108639(21)29079, with serial numbers 29076 and 29079. The distribution is worldwide, including US Nationwide and countries such as Argentina, Australia, and others.

What You Should Do

Consumers should follow the initial firm notification, which was a letter, for instructions from Philips North America regarding this voluntary recall.

Why This Matters

This recall affects medical devices used in imaging, potentially leading to inaccurate results that could impact diagnostic processes. It underscores the importance of ensuring reliability in healthcare equipment.

Source

Attribution: FDA. Recall information is from the FDA database, recall number Z-1960-2026.

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 seven units of Ingenia Ambition S with MR Elastography due to potential stiffness value errors in imaging 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.