Philips Ingenia 3.0T Device Recall Announced
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 64 units of Ingenia 3.0T with MR Elastography devices due to potential errors in stiffness value measurements.
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, 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 the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Which Products Are Affected
The affected products are Philips Ingenia 3.0T with MR Elastography devices with the following model numbers: 781342, 781377, and 782103. The 510(k) numbers associated are K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, and K251808. A total of 64 units are affected, distributed US Nationwide and in countries including Argentina, Australia, and others. Specific UDIs and serial numbers for each model are provided in the recall details, such as for model 781342: UDI (01)00884838055339 with serial numbers like 71693, 71581, and more.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact Philips North America for further instructions regarding the recall.
Why This Matters
This recall affects medical devices used in diagnostics, potentially leading to inaccurate results that could impact patient care; it involves 64 units distributed worldwide, highlighting the need for accurate medical equipment.
Source
From the FDA, recall number Z-1958-2026.
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 (1,419 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.