Recall of Philips Ingenia Elition X 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 103 units of Philips Ingenia Elition X with MR Elastography devices due to potential stiffness value errors in imaging.
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 Philips Ingenia Elition X with MR Elastography devices because of 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 include:
- Model Number (REF): 781358, with various UDIs such as (01)00884838088115(21)45121 and serial numbers including 45121, 45148, among others.
- Model Number (REF): 782107, with various UDIs such as (01)00884838098336(21)45590 and serial numbers including 45590, 62158, among others.
- Model Number (REF): 782136, with various UDIs such as (01)00884838108608(21)28568 and serial numbers including 28568, 28503, among others. A total of 103 units are affected, distributed worldwide, including the United States and countries such as Argentina, Australia, and Canada. The recall involves 510(k) numbers: K213516, K223458, K230972, K232030, K251397, and K251808. The official recall number is Z-1963-2026.
What You Should Do
Consumers and users should follow the initial firm notification, which was issued via letter, and contact Philips North America for instructions on the recall.
Why This Matters
This recall affects 103 medical devices used in imaging, potentially leading to inaccurate results that could impact patient care; it underscores the need for precise medical equipment to ensure reliable healthcare outcomes.
Source
FDA Enforcement Report, Recall Number: Z-1963-2026. For more information, refer to the FDA website.
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 (1,665 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.