Recall of Philips Achieva 1.5T Devices Due to Potential Errors
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Philips North America is recalling three units of Philips Achieva 1.5T with MR Elastography devices because of potential stiffness value errors in image reconstruction.
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 the Philips Achieva 1.5T with MR Elastography 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 in the default MRE scan protocol displaying too small.
Which Products Are Affected
The affected products are Philips Achieva 1.5T with MR Elastography, specifically:
- Model Number: 781196, Serial Number: 21957
- Model Number: 781296, Serial Numbers: 32039 and 32095, with UDI: (01)00884838004108(21)32039 and (01)00884838004108(21)32095 A total of 3 units are affected. These products were distributed worldwide, including US Nationwide and countries such as Argentina, Australia, and others.
What You Should Do
Consumers with these devices should contact the recalling firm, Philips North America, as per the initial firm notification, which was a letter, for instructions on the recall. The recalling firm is located at 222 Jacobs St, Cambridge, MA 02141-2296.
Why This Matters
This recall affects medical devices that could lead to inaccurate results, potentially impacting diagnostic procedures in a way that may cause temporary or reversible health consequences.
Source
FDA Recall Number: Z-1951-2026. 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 (1,372 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.