Recall of Philips Ingenia 1.5T CX Medical Device
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 one unit of the Ingenia 1.5T CX with MR Elastography due to potential errors in stiffness value measurements from specific image reconstruction parameters.
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, fda, Devices.
Recall Article
What Happened
Philips North America is initiating a recall for the Ingenia 1.5T CX with MR Elastography 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 product is the Philips Ingenia 1.5T CX with MR Elastography, Model Number: 781262. Only 1 unit is involved, with Serial Number: 77144 and UDI: (01)00884838068445(21)77144. This recall applies to products distributed worldwide, including the United States and other countries such as Argentina and Australia.
What You Should Do
Consumers with the affected unit should contact the recalling firm, Philips North America, as per the initial notification letter for instructions on handling the product.
Why This Matters
This recall is significant because it could result in inaccurate medical imaging results, potentially affecting diagnostic accuracy, though the risk of serious health consequences is considered remote.
Source
This information is attributed to the FDA. For details, refer to the FDA recall page for recall number Z-1957-2026.
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 (1,269 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.