Philips Ingenia 1.5T Devices Recall Over Stiffness Value Errors
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 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, cpsc, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
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 ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.