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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,584 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.