Philips Ingenia 1.5T Devices Recall Over Stiffness Value Errors
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Philips North America is recalling 54 units of Philips Ingenia 1.5T with MR Elastography devices due to potential errors in stiffness values 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, cpsc, Devices.
What Happened
Philips North America is recalling certain Philips Ingenia 1.5T with MR Elastography 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 reconstruction voxel size settings displaying too small in the default MRE scan protocol.
Which Products Are Affected
The affected products are Philips Ingenia 1.5T with MR Elastography devices with the following model numbers: 781315, 781341, 781396, and 782115. A total of 54 units are involved. Specific UDIs and serial numbers include: For model 781315: UDI (01)00884838099715 with serial numbers 61067, 61058, 61056; for model 781341: UDI (01)00884838055322 with serial numbers 70229, 84667, 70311, 70668, 70845, 70851, 87151, 87112, 84322, 84323, 84228, 84789, 84261, 84500, 84556, 87187, 84840, 70685, 84661, 70787, 70063, 70621, 70743, 70911, 84049, 84088, 84147, 84254, 84283, 84403, 84433, 84460, 84462, 84467, 84475, 84498, 84538; for model 781396: UDI (01)00884838009820 with serial numbers 41175, 41108, 41395, 41037, 41066, 41098, 41194, 41208, 41354, 41356, 41370, 41552; for model 782115: UDI (01)00884838099043 with serial numbers 61214, 61221. These devices were distributed worldwide, including US Nationwide and countries such as Argentina, Australia, and others.
What You Should Do
Consumers with affected devices should contact Philips North America as the recall was initiated via letter for further instructions on the voluntary recall.
Why This Matters
This recall involves 54 medical devices that could lead to inaccurate stiffness values in imaging, potentially affecting diagnostic outcomes; it highlights the importance of precise medical equipment in healthcare.
Source
Attribution: FDA Recall Notice Z-1956-2026
Original source: FDA Official Notice ↗
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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 (1,831 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.