Recall of Philips Ingenia 3.0T CX 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 22 units of Ingenia 3.0T CX with MR Elastography due to potential stiffness value errors in the scan protocol.
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.
What Happened
Philips North America is recalling certain medical 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 incorrect reconstruction voxel size settings in the default MRE scan protocol.
Which Products Are Affected
The affected products are Philips Ingenia 3.0T CX with MR Elastography. Model Numbers: 781271 and 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808. A total of 22 units are affected. Specific UDIs for Model 781271 include (01)00884838068452 with various serial numbers: 78017, 78013, 78014, 78034, 78058, 78073, 78075, 78092, 78112, 78123, 78201, 78202, 78215, 78217, 78239, 78247, 78260, 78286, 78287, 78026. For Model 782105, UDIs include (01)00884838098312 with serial numbers: 78532, 78576. Distribution is nationwide in the United States and worldwide to countries including Argentina, Australia, and others.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact the recalling firm, Philips North America at 222 Jacobs St, Cambridge, MA 02141-2296, for further instructions.
Why This Matters
This recall involves medical devices that could produce inaccurate results, potentially impacting diagnostic accuracy in healthcare settings; it affects 22 units distributed globally, highlighting the need for precise medical equipment.
Source
FDA Recall Number: Z-1959-2026; for more information, visit the FDA website and search for event ID 98779.
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 (1,606 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.