Philips Ingenia Elition S Recall Due to Potential Errors
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 six units of specific Ingenia Elition S MRI devices because of potential stiffness value errors in the scan protocol, affecting devices distributed nationwide in the US and internationally.
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 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.
What Happened
Philips North America has initiated a recall 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 products are Philips Ingenia Elition S with MR Elastography (MRE), with the following model numbers: 781357, 782106, and 782137. The recall involves a total of 6 units, including specific serial numbers: for model 781357, serial number 46002; for model 782106, serial numbers 46243, 46292, and 46317; for model 782137, serial numbers 64034 and 64045. These units were distributed worldwide, including nationwide in the United States and in countries such as Argentina, Australia, and others. The recall number is Z-1962-2026.
What You Should Do
Consumers who have these devices should contact Philips North America for instructions, as the initial notification was made via letter. For returns or refunds, reach out to the recalling firm at their address: 222 Jacobs St, Cambridge, MA 02141-2296.
Why This Matters
This recall highlights potential issues in medical imaging devices that could lead to inaccurate diagnostic results, underscoring the importance of device accuracy in patient care.
Source
This information is from the FDA recall notice, recall number Z-1962-2026. For more details, visit the FDA website.
Original source: FDA Official Notice ↗
Related FDA Recalls
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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 (1,483 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 14, 2026.
Frequently Asked Questions
Common questions about this FDA recall.