Recall of Philips Ingenia Ambition S Devices
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.
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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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